tag:blogger.com,1999:blog-82783268530061663802024-03-05T00:49:23.300-08:00Medical Affairs ManagementMedical Affairs Management Medical Affairs Service Medical Affairs India
Medical affair Medical affairs organization
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.comBlogger29125tag:blogger.com,1999:blog-8278326853006166380.post-28436155759706495982022-02-01T08:56:00.004-08:002022-02-01T08:56:24.139-08:00Gigantic Influences of Medical Affairs in Healthcare Industry<p> <span style="background-color: white; color: #292929; font-family: charter, Georgia, Cambria, "Times New Roman", Times, serif; font-size: 20px; letter-spacing: -0.06px;">Medical Affairs are departments within pharmaceutical and medical device companies responsible for communicating accurate information to healthcare providers. Medical Affairs acts as a bridge between the industry and the broader community of healthcare providers. This department is responsible for managing external relationships with major thought leaders in the scientific community across a wide range of therapeutic fields, as well as patient groups, authorities, and other stakeholders.</span><span style="background-color: white; color: #292929; font-family: charter, Georgia, Cambria, "Times New Roman", Times, serif; font-size: 20px; letter-spacing: -0.06px;"> </span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEjfdxGYTO71B_k7ZB-nvNKiZ1tZ3wkKGjwx-v4600SjW86dqJY9xCaFUlCjRopGeIojYFkFE2ngyG86oUGf75jyOTf01q9x7BxhlaB1a3imGaVDMbs8qxd86ko95KKrHVVaYXu8dCfbgaTa64n1kSMskyT6sqWaoxYYkDtSRZ1zlnt9a8YrMr8d5-nl=s903" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="903" data-original-width="896" height="552" src="https://blogger.googleusercontent.com/img/a/AVvXsEjfdxGYTO71B_k7ZB-nvNKiZ1tZ3wkKGjwx-v4600SjW86dqJY9xCaFUlCjRopGeIojYFkFE2ngyG86oUGf75jyOTf01q9x7BxhlaB1a3imGaVDMbs8qxd86ko95KKrHVVaYXu8dCfbgaTa64n1kSMskyT6sqWaoxYYkDtSRZ1zlnt9a8YrMr8d5-nl=w549-h552" width="549" /></a></div><div class="separator" style="clear: both; text-align: center;">Medical Affairs in Healthcare Industry</div><p><span style="background-color: white; color: #292929; font-family: charter, Georgia, Cambria, "Times New Roman", Times, serif; font-size: 20px; letter-spacing: -0.06px;">WorkSure®</span><a class="au jb" href="https://www.worksure.org/services/medical-affair-management/" rel="noopener ugc nofollow" style="-webkit-tap-highlight-color: transparent; background-color: white; box-sizing: inherit; font-family: charter, Georgia, Cambria, "Times New Roman", Times, serif; font-size: 20px; letter-spacing: -0.06px;" target="_blank"> Medical Affair</a><span style="background-color: white; color: #292929; font-family: charter, Georgia, Cambria, "Times New Roman", Times, serif; font-size: 20px; letter-spacing: -0.06px;"> services include medico-marketing and business development, medical communication, medical education and training, clinical research and regulatory activities, as well as </span><a class="au jb" href="https://www.worksure.org/services/medical-affair-management/" rel="noopener ugc nofollow" style="-webkit-tap-highlight-color: transparent; background-color: white; box-sizing: inherit; font-family: charter, Georgia, Cambria, "Times New Roman", Times, serif; font-size: 20px; letter-spacing: -0.06px;" target="_blank">KOL management</a><span style="background-color: white; color: #292929; font-family: charter, Georgia, Cambria, "Times New Roman", Times, serif; font-size: 20px; letter-spacing: -0.06px;"> and interfacing responsibilities. WorkSure® Medical Affairs service provides a comprehensive solution for pharmaceutical and healthcare organizations that deal with customers, patients, regulatory authorities, and doctors. With years of experience in therapeutic-based practices, our experienced team is well suited to assist our global clients with day-to-day challenges in the pharmaceutical industry. WorkSure® strives to meet the needs of its clients and provide complete product support.</span></p><p><span style="background-color: white; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px;">Read more at </span><a data-attribute-index="36" href="https://lnkd.in/gyM55BqA" style="background-color: white; border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">https://lnkd.in/gyM55BqA</a><br style="background-color: white; box-sizing: inherit; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; line-height: inherit !important;" /><br style="background-color: white; box-sizing: inherit; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; line-height: inherit !important;" /><a data-attribute-index="1" href="https://www.linkedin.com/feed/hashtag/?keywords=medicomarketing&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A6894224100760416256" style="background-color: white; border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">#medicomarketing</a><span style="background-color: white; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px;"> </span><a data-attribute-index="2" href="https://www.linkedin.com/feed/hashtag/?keywords=medicalaffaris&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A6894224100760416256" style="background-color: white; border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">#medicalaffaris</a><span style="background-color: white; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px;"> </span><a data-attribute-index="3" href="https://www.linkedin.com/feed/hashtag/?keywords=kolmanagement&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A6894224100760416256" style="background-color: white; border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">#kolmanagement</a><span style="background-color: white; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px;"> </span><a data-attribute-index="4" href="https://www.linkedin.com/feed/hashtag/?keywords=medicaleducation&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A6894224100760416256" style="background-color: white; border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">#medicaleducation</a><span style="background-color: white; color: rgba(0, 0, 0, 0.9); font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px;"> </span><a data-attribute-index="5" href="https://www.linkedin.com/feed/hashtag/?keywords=medicalcommunications&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A6894224100760416256" style="background-color: white; border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-family: -apple-system, system-ui, BlinkMacSystemFont, "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 14px; font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">#medicalcommunications</a></p>WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0tag:blogger.com,1999:blog-8278326853006166380.post-59872178833621518202021-12-31T05:26:00.000-08:002021-12-31T05:26:10.591-08:00Happy New Year 2022<iframe frameborder="0" height="270" src="https://youtube.com/embed/VAyFCnWv9AI" width="480"></iframe><div><br /></div><div>WorkSure wishes everyone Happy New Year 2022</div><div><br /></div><div>#contractresearchoganization #clinicaldatamanagement</div>WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0tag:blogger.com,1999:blog-8278326853006166380.post-6659666377424165492015-11-14T02:03:00.002-08:002015-11-14T02:06:42.770-08:00Pharmacoeconomics: quantify the value of pharmacotherapy through balancing costs and outcomes<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhWhCrYd3eqIciAd4rme10M9EA4Pwu91GdomyLuUvwu_ir2N2nYTFj1rLnPkM8PmqwkLnZkK69XyngG2N293lpxSyNiKvSPoxGHpt6hoGSDHAgZ0V7CjR4rLhrSwLpmQJwiaIYYW4-94co/s1600/Feb20_2014_38337746_RedWhitePillDollars_Pharmacoeconomics1907513412.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="202" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhWhCrYd3eqIciAd4rme10M9EA4Pwu91GdomyLuUvwu_ir2N2nYTFj1rLnPkM8PmqwkLnZkK69XyngG2N293lpxSyNiKvSPoxGHpt6hoGSDHAgZ0V7CjR4rLhrSwLpmQJwiaIYYW4-94co/s320/Feb20_2014_38337746_RedWhitePillDollars_Pharmacoeconomics1907513412.jpg" width="320" /></a></div>
Pharmacoeconomics (PE), a sub discipline of health economics, evaluates the behavior of individuals, firms, and markets relevant to the use of pharmaceutical products, services, and programs, and with the focus on the costs (inputs) and consequences (outcomes) of that use. Cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis and cost-benefit analysis are the four techniques commonly used for economic evaluation, but vary in measurement of value of health benefits and outcomes. PE assessment of formulary actions has become a standardized part of many pharmacy and therapeutic committees (PTC). PE studies are also helpful in fixing the price of a new drug and re-fixing the price of an existing drug, finalizing a drug formulary, creating data for promotional materials of medicines, compliance of requirement for drug license, including a drug in the medical/insurance reimbursement schemes, introduction of new schemes and programs in hospital pharmacy, drug development and <a href="http://blog.worksure.org/clinical-trial-services/">clinical trials</a> PE has use in health policy decision making and can be applied by a number of healthcare professionals such as policy makers, primary healthcare providers, health-care administrators, and health managers. </div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com2tag:blogger.com,1999:blog-8278326853006166380.post-81148234166925518942015-10-05T05:22:00.001-07:002015-11-14T02:08:24.557-08:00Excellence in regulatory documentation rendered by medical writer<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhISBKtvxPB3IB2xrAvmak12oCuhE6qVslpmALFw0BrIZHLHpFLdW6u9Ot14uqcMPUVDs42VKgY4axHNeAHD1kGhqXyzU8hbUmeRyeexqo6hFM3J1_VBKE-9Arc8KBPARZb3-E5YEbYSD8/s1600/i--social_media-istockphotos-regulatory_writers.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="212" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhISBKtvxPB3IB2xrAvmak12oCuhE6qVslpmALFw0BrIZHLHpFLdW6u9Ot14uqcMPUVDs42VKgY4axHNeAHD1kGhqXyzU8hbUmeRyeexqo6hFM3J1_VBKE-9Arc8KBPARZb3-E5YEbYSD8/s320/i--social_media-istockphotos-regulatory_writers.jpg" width="320" /></a></div>
<a href="http://blog.worksure.org/regulatory-medical-writing/">Regulatory Medical writing</a> is an activity of writing scientific documents which are pivotal for the approval of any new drug or device. A team of specialized medical writers are involved in the preparation of Investigational Medicinal Product Dossier (IMPD), <a href="http://blog.worksure.org/clinical-trial-application-cta-submission-in-india/">Clinical Trial Application</a> (CTA), Common Technical Document (CTD), Investigational New Drug (IND) & New Drug Application (NDA). The regulatory medical writers must have the good knowledge of new and changing global regulations and ICH guidelines to meet the requirement of sponsor. At WorkSureTM we have the capability to work for regulatory framework of various countries including USA, Canada, Europe, Japan, India etc. </div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com4tag:blogger.com,1999:blog-8278326853006166380.post-87508821143438250392015-10-05T05:19:00.003-07:002015-11-14T02:10:59.904-08:00Industries are helping medical research and communication activities<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjy5FAXB3E0egzXUBmed9Eu6PhJcP0BjKKXwSgL-VE571_fs6N2YgBt5NPa5cNC2akRpbLes2JM6M04UQdguXJtVhNSJG-5qXkX8jGJYcwPnmxc3clIl9mANO2Th3QCxZv9RZtKa-kREdg/s1600/medical-research.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjy5FAXB3E0egzXUBmed9Eu6PhJcP0BjKKXwSgL-VE571_fs6N2YgBt5NPa5cNC2akRpbLes2JM6M04UQdguXJtVhNSJG-5qXkX8jGJYcwPnmxc3clIl9mANO2Th3QCxZv9RZtKa-kREdg/s320/medical-research.jpg" width="320" /></a></div>
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Newer treatments and bettering healthcare services are increasing life expectancy with improved quality of life. Various pharmaceutical, biotech industries and medical service KPOs are stepping forward to facilitate delivery of evidence based health care to the patients. WorkSure™, a growing name in healthcare KPO, has taken FMRC (<a href="http://blog.worksure.org/facilitation-of-medical-research-and-communication-fmrc/">Facilitated Medical Research Communication</a>) initiative to help bridge the gap and increase India's share in biomedical research. This unique program is specially designed for assisting the Healthcare Fraternity to promote <a href="http://blog.worksure.org/medical-research/">medical research</a> at the level of hospitals, clinics as well as individual physician. WorkSure™ also promotes public private partnership in medical research and drug development.</div>
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0tag:blogger.com,1999:blog-8278326853006166380.post-54241579314953928362015-09-28T05:50:00.003-07:002015-09-28T05:50:54.155-07:00Regulatory Medical writers A Document Focused Scientific experts<div dir="ltr" style="text-align: left;" trbidi="on">
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGUZ1MalKtByb6g1hyxWE03ds4l8t9yYHN2bk23nneg8GqBZg2_2EGuOGNDpe4MJRpoj9Rqyc8yyjR9q1bnEsmHSbHXg4G7OId-AOn6PnX2yX0UO0h0pb6XXmI0da61lphbDWcKLEMsY8/s1600/address.png" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" height="170" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGUZ1MalKtByb6g1hyxWE03ds4l8t9yYHN2bk23nneg8GqBZg2_2EGuOGNDpe4MJRpoj9Rqyc8yyjR9q1bnEsmHSbHXg4G7OId-AOn6PnX2yX0UO0h0pb6XXmI0da61lphbDWcKLEMsY8/s320/address.png" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://www.worksure.org/">WorkSure</a></td></tr>
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<span style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman";"><a href="http://blog.worksure.org/medical-writer/">Medical writer</a> plays an important role in providing information to the targeted
audience. Regulatory medical writing
involves regulatory documents that are required before the approval of drug.
All new drug or chemical entity undergoes many level of test for its purity,
safety and efficacy. These include clinical study protocol, clinical study
report, patient consent form, summary document (common technical document).</span><span class="apple-converted-space"><span style="background: white; color: #252525; font-size: 12.0pt; line-height: 150%;"> </span></span><span style="background: white; color: #252525; font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman";">It is an internationally agreed format for the preparation of
applications regarding new drugs. It was developed by EMA, Europe (European
medical agency), FDA (Food and Drug Administration), MHLW, Japan (Ministry of
Health and Labour Welfare). The CTD is maintained by ICH (International
Conference of Harmonisation). The regulatory documents required are INDA
(Investigational New Drug Application), NDA (New Drug Application), and ANDA
(Abbreviated New Drug Application. </span><span style="font-size: 12pt; line-height: 150%;">The
regulatory writer prepares the document to be reviewed by FDA and for further
proceeding with the <a href="http://blog.worksure.org/clinical-trial-services/">clinical trials</a>.</span><span style="background: white; color: #252525; font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman";"> The strength of medical writer depends on its experience and
ability to understand well the regulation requirement by the corresponding
agengies. Other regulatory documents </span><span style="background: white; font-size: 12pt; line-height: 150%;">like </span><span class="apple-converted-space"><span style="font-size: 12pt; line-height: 150%;">Product</span></span><span style="font-size: 12pt; line-height: 150%;">
Monograph, Full Prescribing Information, Patient Information Leaflet, Summaries
of Product Characteristics (SPCs), Risk Evaluation and Mitigation Strategies
(REMS) etc. for both drugs and devices also be a part of regulatory document. </span><span style="background: white; color: #252525; font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman";">The drug safety, quality, strength and purity
is assured by NDA to permit FDA for final submission. <o:p></o:p></span></div>
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<span style="background: white; color: #252525; font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman";">The regulatory medical writer is an expert and
more specific than any other writer as they have to deals with the regulations
in ICH which involves application submission, withdrawal and termination of
particular drug. The regulatory medical writing team also involved in preparing
dossier, protocols for all clinical trial phases and application for INA, NDA,
CTA. As the detailed study of the drug
is to be compiled and documented, the writer must know about the statistical
analytical processes (SAP). They must be having good knowledge about the new
regulations and amendments in ICH. In pharmaceutical organisation and clinical
research organisation, the writer must be active to submit the information to
the regulatory agency when needed. The medical writer has the primary
responsibility for documentation of the specific areas such as CMC (Chemistry
Manufacturing Control), clinical and non-clinical. After the protocol
development at the clinical sites, the regulatory medical writer review SAP,
followed by clinical study report. The writer has ability to complete and
concise CSR that shows the result of clinical trials. Finally the results of
each CSR are to be submitted to the regulatory authority. This procedure from
developing protocol to the submission of document is undertaken by regulatory
medical writer. The work of regulatory medical writer is wide-ranging. They
have to face many challenges in pharmaceutical and clinical research
organisation. As an individual they have to look into the protocol design in
order to produce proper data out of the clinical trials necessary for labelling
of product, support in data analysis, and summarises the complicated data.
Additionally, Regulatory medical writer is always anticipated in the query resolution
and for advancement to the sponsors.<o:p></o:p></span></div>
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<span style="background: white; color: #252525; font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman";">We at WorkSure<sup>TM</sup> have a specialized
team of <a href="http://blog.worksure.org/regulatory-medical-writing/">regulatory medical writer</a>. We deal with all type of regulatory document
IND, NDA and CTD. We are also involved in generating protocols for all phases
of clinical trials. We have the capability to work for regulatory agencies of
various countries including USA, Canada, Europe, Japan, India etc.<o:p></o:p></span></div>
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com4tag:blogger.com,1999:blog-8278326853006166380.post-43481081153068278962015-01-03T04:46:00.003-08:002015-01-03T04:53:32.206-08:00WorkSure one stop guide for Medical Writing service<div dir="ltr" style="text-align: left;" trbidi="on">
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<b><span style="font-size: x-large;">M</span>edical writing</b> involves communication of clinical and scientific data to wide range of audiences in various formats. A competent medical writer is one who has thorough knowledge of medical concepts and terminology, understanding of guidelines, flair for writing skills and good command over the language. Medical writers combine their scientific and rhetoric skills in order to present the information in accordance with the target audience. <a href="http://www.worksure.org/pages/medical-writing-training.html">Medical writing</a> involves writing of different documents viz regulatory and research-related documents, publication articles like journal manuscripts and abstracts, educational and promotional writing, content for healthcare websites, health-related magazines or news articles.</div>
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<a href="http://blog.worksure.org/medical-writing/"><b>Medical writing</b></a> for the pharmaceutical industry comprises of either regulatory medical writing or educational medical writing. Regulatory medical writing involves preparing scientific documents for submission to regulatory agencies for getting approval of pharma drugs, medical devices & biologics. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents e.g. in common technical documents that summarize and discuss the data a company gathers in the course of developing a medical product.</div>
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Educational writing is one which describes the profile of drugs or devices to the general audience or to a medical professional. It also includes promotional writing. Promotional writing mainly comprises of product profile writing, drug related educational & promotional literature, ads etc. used by the healthcare industries for promoting their products. It also includes sales literature, product information leaflets, summary of product literature, journals, articles, manuscripts, slide presentation for conference.
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<b>WorkSure™ MedPharma Consultancy (WMC),</b> a first Medical Service KPO in India, comprises of a team of enterprising, highly qualified and experienced professionals who are committed to achieve complete client satisfaction through timely quality work. We at WorkSure™ support in planning, performing and communicating research through preparation of various clinical, promotional, regulatory and educational documents. </div>
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WorkSure, a first Healthcare Service KPO in Indian, is a group of highly qualified and experienced professionals from top institutions of Indian like AIIMS, PGI & IIT. We work on three business models. First of all as efficient knowledge partners with dedicated group for medical composing, medical matters, medical information control, biostatistics, <a href="http://blog.worksure.org/pharmacovigilance-services/">pharmacovigilance</a> & coaching.</div>
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Secondly, we offer personalized stand-alone alternatives in pre-clinical & medical scientific research. We offer medical composing alternatives for planning of safety reports like ICSR, PSUR. We offer mathematical research of report/data and regulating support solution. We offer regulating alternatives for planning of <a href="http://blog.worksure.org/clinical-trial-application-cta-submission-in-india/">Clinical Trial Program</a> (CTA), Investigational Therapeutic Product File (IMPD), Investigational New Medication (IND) & New Medication Program (NDA), medical information alternatives and KOL control.</div>
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Thirdly, we have end to end alternatives for medical composing, scientific research coaching and site development, medical information control (CDM) and biostatistics for pre-clinical, medical and scientific research. </div>
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We offer a specific package for handling medical information right from information control plan to its removal for research and final confirming, with helpful mathematical & medical composing alternatives. With such a variegated outdoor umbrella of specific alternatives, WorkSure is an growing leader among <a href="http://blog.worksure.org/clinical-research/">Clinical Research</a> Companies setting new requirements in this field.</div>
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com3tag:blogger.com,1999:blog-8278326853006166380.post-62841752547860485372014-11-28T03:52:00.000-08:002014-11-28T04:03:28.374-08:00Clinical Data Management System Helping to fast-track the drug development process<div dir="ltr" style="text-align: left;" trbidi="on">
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<h2>
Clinical Data Management System</h2>
<span style="font-size: x-large;">I</span>n today's research scenario, clinical trials find answer to the research questions by the means of generating data for proving or disproving a hypothesis. This produces large sum of clinical data which has to be organised in most reliable and flexible manner under an efficient management system called as Clinical Data Management (CDM). <a href="http://blog.worksure.org/clinical-data-management/">Clinical Data Management Services</a> has now gradually developed its response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation. The main objectives of CDM process is to collect the raw data, ease in monitoring or auditing, and to facilitate processing of the data. </div>
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<span style="font-size: x-large;">C</span>linical Data Management System
CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards and thus adoption of CDM to drive forward drug research is gaining pace worldwide. It is found that CDM is the key corporate asset in today’s <b><u>biopharmaceutical</u></b> industry, and turning data into meaningful information is a critical core function for sponsor firms to make faster and more flexible assessment of the compounds with a specific indication. In forthcoming trials, a CDMS has become necessary to manage the huge amount of data. Many of the CDMS used in pharmaceutical companies are commercial, but there are few open source tool also. These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality. The open source software can be downloaded from their respective websites.</div>
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<u><span style="font-size: x-large;">E</span>lectronic Data Capture (EDC)</u> is an alternative which helps to reduce the clinical research cost by 20-28%. The use of <u>EDC technology</u> and eCRF to collect data in clinical trials has grown in recent years and has affected the activities of <a href="http://blog.worksure.org/clinical-research/">clinical research</a> operations for industry sponsors, <b>contract research organizations</b> (CROs), and clinical sites. It is found that cost savings alone with EDC vs paper estimated about $60 million per drug. To encounter the particular demand, there is a constant shift from the paper-based to the electronic systems of data management. Developments on the technological front have positively impacted the CDM process and systems, thereby helping encouraging results on speed and quality of data being generated.</div>
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<span style="font-size: x-large;">W</span>hile companies are seeking faster access to clinical data, the integrity and quality of data being collected and transferred from study subjects to a clinical data management system (CDMS) must be monitored maintained, and quantified. This ensures a reliable and effective base for not only new drug application (NDA) submission and clinical science reports but also corporate clinical planning, decision-making, process improvement, and operational optimization. FDA has brought forward a critical path initiative in pushing study data tabulation model (SDTM) adoption to enable electronic regulatory submissions for sponsors of human drug clinical trials. SDTM was initiated and developed by CDISC. As a consequence, biopharmaceutical companies have been going major changes in re-evaluating their IVRS, CDMS, <a href="http://blog.worksure.org/clinical-research-clinical-trials-management/">clinical trial management system</a> (CTMS), and clinical safety system (CSS) to accommodate the growing needs and demands.</div>
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<span style="font-size: x-large;">I</span>n conclusion, CDMS has now been emerged as an important and reliable tool to materialize the clinical data into useful information which can be further considered to establish as research evidence. Moreover, speed and efficiency of CDMS has also contributed to fast track the drug development process. </div>
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com2tag:blogger.com,1999:blog-8278326853006166380.post-91654974287403735452014-11-12T02:44:00.002-08:002014-11-12T03:00:16.016-08:00Electronic health records<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxQVu8Xe23XR5vpmoi2g1zw04I94DiimnHbMPCztwSdzLXr4pqAPPQ8rW9QT6VzRNgDOO1jbYBORmEy4MXniH-BLe0F9P9vh42bX7Jlus3Vj2QhxxL27w5X_hoxyqV2AREtTqvD8jTwMs/s1600/electronic1.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxQVu8Xe23XR5vpmoi2g1zw04I94DiimnHbMPCztwSdzLXr4pqAPPQ8rW9QT6VzRNgDOO1jbYBORmEy4MXniH-BLe0F9P9vh42bX7Jlus3Vj2QhxxL27w5X_hoxyqV2AREtTqvD8jTwMs/s320/electronic1.jpg" width="248" /></a></div>
The Health care industry has undergone dramatic changes over the last few decades. Most of changes revolve around gathering of information and these changes undoubtedly affect both providers and patients. The use of information technology gives access to gather health related information systematically and thereby improves the quality and efficiency of patient healthcare. With the emergence of EHR, the doctors can now instantly access the complete medical information and clinical records of patients on a routine basis.<br />
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An Electronic Health Records (EHR) is a digital record of an individual patient collected in computerized format in order to share medical report among multiple healthcare agencies. Digitized health information is a developing concept which can provide very effective and quality solutions for patient care besides helping in reducing costs.<br />
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The system is designed to feed all the appropriate conditions of an individual patient or population in a digital format that is theoretically shared across different health care settings. Sharing can also be done by means of network-connected, management information systems and other information networks or exchanges.<br />
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In other way, Electronic health record is a source of communication between multiple health care providers to organize, store and manage health data as well as to coordinate a safe, secure and accurate data of an individual patient.<br />
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This record constitutes the heart of e-Health that can be implemented for various public health programs for achieving human development in the field of health sector.<br />
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<b>Among other types of data, an EHR typically includes:</b><br />
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<li>Contact information.</li>
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<li>Medical history of patient.</li>
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<li>Medication and allergies.</li>
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<li>Insurance information.</li>
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<li>Immunization status.</li>
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<li>Information about any conditions or diseases.</li>
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<li>Records of hospitalization.</li>
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<li>Information about any surgeries or procedures performed.</li>
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<li>Billing information.</li>
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<li>Family history.</li>
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The governments of many countries are working to ensure that all citizens have standardized electronic health records including the same type of information. However, the major barrier for the adoption of electronic health records is due to high cost involvement.<br />
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<b>Functions of Electronic health record systems:</b><br />
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<li>Create unique record for each patient including analysis of demographic information of patients</li>
<li>Helps in updating patient history</li>
<li>Act as source of communication between the professionals and patient records.</li>
<li>Lists patient allergic medications and other factors and helps in separating these drugs from a list of common drugs</li>
<li>Stores all the data right from the early stage to the final and provides whenever needed</li>
<li>Has the ability to register without re-entering medication order by initial data entry from previous data (template for reuse)</li>
<li>Allows storing of laboratory results and displays the normal and abnormal results</li>
<li>Describes & documents the oral communications and telephone orders for patient</li>
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<b>Advantages of Electronic Health Record</b><br />
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<li>The entire patient history can be easily viewed without previous medical records and assists in providing accurate, appropriate and legible data.</li>
<li>The chance of replication or duplication is reduced as there is only one single file which is constantly updated and it also eliminates the problem of lost forms or paperwork.</li>
<li>It is an effective method for extracting medical data for further changes in examination of the patient’s medication profile.</li>
<li>Medical records of more than one patient can be easily extracted from EHR database and can be used to gain common characteristics information for other patients, which help in easily and quickly prediction of a disease.</li>
<li>Electronic health records are capable of storing, processing or transferring data to the physician far from their patients simultaneously by proper equipment information and communication technology.</li>
<li>Electronic health records are very much in demand in healthcare practice and enables professionals to interact with each other effectively. The health data management services mainly use EHR for storing all the information.</li>
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<b>Implementing an EMR system</b><br />
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Implementing an EMR system requires careful planning and strong knowledge of trained staff. The following can help make successful implementation of an EMR system at your office.<br />
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<li>Choose your TPA(third-party application) carefully</li>
<li>Ensure connectivity</li>
<li>Develop workable templates</li>
<li>Training the Staff</li>
<li>Establish data security system</li>
<li>Prepare EHR details</li>
<li>Create harmony between the standard organizations and all interested groups and sub-organizations.</li>
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<b>Barriers to implementing an EHR system</b><br />
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<ol style="text-align: left;">
<li>Incorporation of older paper data into the EHR system</li>
<li>Imprecise preservation and long term storage of records</li>
<li>Difficulty in Synchrony records</li>
<li>Inadequacy of Privacy concern</li>
<li>Incompatible with older technology</li>
<li>Software maintenance costs</li>
<li>Higher costs involved in implementation of a customized system initially.</li>
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Due to the challenges and complexities of electronic health records, few people feel uneasy about using electronic medical record software for storing their medical data. On the other hand, there are many people who prefer electronic health records as they feel there is nothing better than digital documentation. </div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com3tag:blogger.com,1999:blog-8278326853006166380.post-88062653060128804822014-10-24T01:42:00.000-07:002014-10-24T01:42:55.113-07:00Medical writing and Regulatory Affairs from WorkSure<div dir="ltr" style="text-align: left;" trbidi="on">
<b>WorkSure A First Medical Service KPO in India</b> is a consultancy organization providing services to Healthcare companies within the Regulatory Solutions, Technical, Medical Affairs, Phamacovigilance and other fields. WorkSure is highly skilled and offers strategic and operation experience combined with company know-how and its strategies, ensuring the rapid fulfillment of excellent results.<br />
The services range from regulatory affairs to preclinical and clinical scientific research, statistical solutions etc. WorkSure ensures efficient support across all areas like medical writing and procedural assistance during the life-cycle of products. WorkSure can also help in editing and review of sponsor prepared documents, SOP preparation and from bio-pharmaceutical studies to initial phases of clinical testing.<br />
<b><u>WorkSure direct interaction with Regulatory Affairs</u></b>, Technical Production, Medical and Marketing Departments ensures high level competence, speed and operation flexibility. Also, they co-operate with the Management and other departments involved in the project to enhance and develop the company portfolio.<br />
<b>Why outsource to WorkSure?</b><br />
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Most companies have adapted the outsourcing strategies that allow maximum flexibility of structuring, minimizing their costs and integrating the company know-how with the skills and capabilities which are specifically hired for individual projects helping management to focus their time, energy and internal resources on strategic activities.<br />
The relationship between the Client and WorkSure is based on trust, mutual understanding as well as working professionalism and the SOP’s we follow. Once the relationship is established, the Client can rely on a professional outsourcing service that is qualified in multiple areas <i><b>(Regulatory Affairs, Pharmacovilance, Medical Writing, Research Solutions, Pre-clinical and Clinical Trials)</b></i> and as the need be.<br />
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<b>How outsourcing can be a useful activity?</b><br />
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a) You receive trained professionals to do your job without requiring hiring a trained staff or training the internal staff.
b) You get the work done from the specialized professionals in strategic areas for the company without require additional resources.<br />
c) Commitments for a limited period and do not require to you recruitment an internal personal.<br />
Worried about certain activities becoming a problem for your company? It is time to consider outsourcing. You decide what you want to outsource and when to do it. WorkSure plays a key role in this respect and can help you plan the most effective service modalities with its experts, in accordance with your needs.<br />
<b>Regulatory Affair Services</b><br />
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WorkSure Regulatory Affairs covers a wide variety of different areas helping companies across the pharma and related industry sectors in helping them manage their daily regulatory affairs along with additional activities which need specific expertise or additional resources. These activities can be partially or fully outsourced. <br />
<b>The primary services include</b><br />
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Medical consultant representation at National Regulatory Authority meetings<br />
Preparation of <u><b>Clinical Trial Application</b></u> (CTA), Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND) & New Drug Application (NDA)<br />
Render support for preparation of medical device submissions eg 510(k) and pre-market approval documentation.<br />
Risk Management Plan / REMS (Risk Evaluation and Mitigation Strategies) and other regulatory documents for clinical trial and drug marketing approval.<br />
Preparing prescribing information, product monographs and product labeling<br />
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The advantage of WorkSure Outsourcing resides in its integrated know-how derived from the experience and knowledge in multiple areas by its staff over the years of work and outsourced projects. This know-how is utilized for the clients by the project leaders who can always count on team work and constant support.</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com1tag:blogger.com,1999:blog-8278326853006166380.post-67992507183020258362014-10-17T00:00:00.002-07:002014-10-17T00:00:34.461-07:00Pharmacovigilance Services from WorkSure<div dir="ltr" style="text-align: left;" trbidi="on">
Life Sciences companies need the operational burden to be taken away so they can focus on the science of safety. They need flexible, scalable operations that run like a well-oiled machine while achieving quality and efficiency objectives. Compliance should be “business as usual” so companies can concentrate their attention on strategic safety governance, benefit-risk management and proactive safety surveillance.<br />
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It is possible to avoid the growing operational problem by moving toward an externally managed solution that consistently and routinely achieves required business outcomes using a globally integrated model. As your partner, WorkSure will deliver <u><b>Pharmacovigilance outsourcing services </b></u>through a global operation with an unprecedented compliance record—no critical findings from audits and inspections by clients’ QA and the regulators.<br />
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WorkSure helps the Life Sciences industry achieve better pharmacovigilance through regulatory compliance, higher productivity, higher quality and strategic safety outcomes.<br />
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<b>Match the solution to the challenge</b><br />
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The need for PV outsourcing is a reality for most Life Sciences companies. As we have implemented these services for our customers, we have adapted according to their operating models, outsourcing maturity level and the scale of the challenge being tackled. We achieve a competitive price point by leveraging our offshore delivery network, and we offer a range of services that can be tailored exactly to match the demands of any context: <br />
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<b>1. Discrete, specific need: </b>Services to augment a PV organization’s existing operations using its own systems and processes; additional capacity provided as needed, with direct oversight of a flexible pool of outsourced resources. <br />
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<b>2. End-to-End Pharmacovigilance: </b>Fully managed service spanning end-to-end pharmacovilance services, integrating seamlessly and using a pharmacovilance organization’s systems and processes; strengthened through our advanced operational excellence capabilities and analytics capability.<br />
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<b>3. Next-generation solution:</b> Fully managed service spanning end-to-end PV services, integrating seamlessly and using a PV organization’s systems and processes; strengthened through our advanced operational excellence capabilities and analytic capability.<br />
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<u><b>Build in quality and mitigate the risk of change</b></u><br />
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Every project does not have to be a large-scale transformation. If you require tactical cost reduction with rapid implementation and the associated control and flexibility, we excel with this model. If you are embarking on a game-changing pharmacovilance transformation, however, introducing our services can be a significant facilitator of that transformation. We will help you drive your vision forward.<br />
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People—patients, healthcare professionals, policy makers and your employees—are at the heart of pharmacovigilance. Our change management and communications experience will help mitigate the risks of adopting new methods, letting you focus on the strategic vision and realize the ultimate patient safety benefits. <br />
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Lean, efficient processes, controlled through compliant standard operating procedures, are the backbone of every service we deliver. We can help you to simplify your global workflow with high throughput, replace manual steps with automation, and build in quality to help you get things right the first time.<br />
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<i><b>Building the future success to Pharmacovilance</b></i><br />
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WorkSure is deeply committed to helping pharmaceutical companies address current challenges as well as pre-empt future issues. Through WorkSure accelerated services, we bring the next-generation, fully integrated business service that delivers optimized processes across the clinical, regulatory and PV functions around the globe. This solution, supported by outsourced operational activities and enabled by customizable technology platforms, helps pharmaceutical companies bring drugs to market faster, at less cost and with reduced execution risks. <br />
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Further, the solution is leading edge, supporting maximum efficiency in R&D as well as the management and measurement of R&D processes. Advanced data analytics drive innovation across companies and help release the full value of the data. By adopting an externally managed solution that consistently and routinely achieves required business outcomes using a globally integrated model, phamacovigilance organizations will gain the freedom to focus on the science of safety.</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0tag:blogger.com,1999:blog-8278326853006166380.post-78169270561133437432014-10-15T02:51:00.001-07:002014-10-15T02:57:50.033-07:00Role Of medical data management services and medical affairs services<div dir="ltr" style="text-align: left;" trbidi="on">
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Clinical data management is a multidisciplinary process which involves collection, integration and validation of clinical trial data in accordance with regulatory standards. It plays a crucial role in clinical research and generates high-quality, reliable, and statistically sound data. <br />
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CDM also reduces the time frame between drug development and marketing. The primary aim of CDM process is to produce high-quality data with minimal error rate. CDM process encompasses Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking. <br />
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Several software tools are available for managing clinical trial data and these are called Clinical Data Management Systems (CDMS). Commonly used CDM tools are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. Among the open source tools, the most prominent ones are OpenClinica, openCDMS, TrialDB, and PhOSCo. These CDM software are available free of cost and equally good as their commercial counterparts in terms of functionality. <br />
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The CDM tools also enable to maintain audit trail of medical data management activities during the clinical trial and thereby help in avoiding discrepancies. Multiple user IDs can be created for each team member with the help of these tools. This assures access only to the function allocated to each user ID and does not allow any other changes in the database. In cases where changes need to be made in the data, the software will record the change made, the user ID that made the change and the time and date of change, for audit purposes (audit trail). <br />
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It is mandatory to follow good practices in CDM and the electronic records have to comply with Code of Federal Regulations (CFR), 21 CFR Part 11.<br />
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Presently, best CDM practices have evolved due to the increasing demands from pharmaceutical companies as well as from regulatory authorities in order to generate high quality data. On the other hand there has been a shift from the paper-based to the electronic systems of data management. There has been a positive influence of technology development on CDM process and systems. CDM should be evaluated through systems that have been put into practice. <br />
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All around the world, company is serving clients with tools in domains like Medical Writing and Research Solutions, Preclinical Clinical and Scientific Research, clinical trials, medical writing training, medical affairs services, medical data management etc.
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com1tag:blogger.com,1999:blog-8278326853006166380.post-27126863984259523692014-10-14T03:22:00.001-07:002014-10-14T03:34:12.235-07:00Clinical Research Coordinator - Roles and Responsibilities<div dir="ltr" style="text-align: left;" trbidi="on">
Clinical Research Coordinator (CRC), research coordinator or site coordinator is a specialized professional who assures uninterrupted and ethical conduct of a clinical trial at institution/hospital. AlthoughPrincipal Investigator (PI) is largely responsible for proper conduct of a clinical study; CRC shares the onus by working in coordination with PI under his supervision. Like PI and co-investigators; the CRC is an integral member of the team who performs clinical trial in accordance with regulatory guidelines and institutional requirements. CRC acts as an intermediary between trial subjects, institution and sponsor on ethical, personal and financialaspects of trial. Largely, CRC remains involved in almost every step of the study.<br />
<u><b>Clinical Research Coordinators performs the following activities:</b></u><br />
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<ol style="text-align: left;">
<li><u><b>CRC collects the updated and signed resume</b></u> of each member of the investigator team. He/she ensures the timely completion of pretrial documents including form 1572, financial disclosure form, undertaking from the PI and confidentiality non-disclosure agreement.</li>
<li><b><u>Helps PI in determining study</u></b> feasibility questionnaire and maintaining liaison with the study sponsor.</li>
<li><u><b>Assists PI in recruiting subjects</b></u> as per the inclusion and exclusion criteria predefined in study protocol.</li>
<li><b><u>Participates in informed consent process</u></b> and ensures that all the trial related questions of participants are answered to their satisfaction. He/she obtains duly signedand dated informed consent forms from subjects. Furthermore, he/sheensures that amendments to consent forms are appropriately implemented and signed.</li>
<li><u><b>Monitors day </b></u>to day progress of trial and reports to concerned authorities.</li>
<li><u><b>CRC ensures timely conduct of protocol</b></u> specified investigation of subjects. CRC also makes sure that specimens are properly labeled, packed and stored before shipping them to labs. He/she keeps track of the reports obtained from laboratories. </li>
<li><u><b>Collects generated dat</b></u>a as per pre-specified protocol and assures timely completion of Case Report Forms. </li>
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<li><u><b>Performs inventory management</b></u> and ensures adequate and continuous supply of investigational drugs/devices and other required materials.</li>
<li><u><b>CRC maintains study documents</b></u>, records and files in accordance with sponsor requirements including but not limited to, consent forms, source documentation, narrative notes etc. Moreover, he/she retains these records as per institution/sponsor requirements for specified time period.</li>
<li><u><b>Assures effective and ongoing</b></u> communication with sponsor, research participants and PI during the course of the study.</li>
<li><u><b>CRC coordinates with investigator</b></u>, sponsor and IRB/IEC to confirm the conduct of trial in agreement with regulatory requirements.</li>
<li><u><b>Actively participates during the monitoring</b></u> visits, audits & inspections by the sponsor’s representative.</li>
<li><u><b>CRC confirms that study</b></u> gets completed as per the specifiedtimelines</li>
<li><u><b>Once the study is closed</b></u>, CRC maintains the inventory of archived documents.</li>
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Thus CRC plays a pivotal role in various activities like conduct of the study, protection of human subjects and eventually successful completion of study. Considering steep rise in number of clinical trials and their overtly complex designs, an expert and well trained CRC has become an obligation for sponsors. Thus, proficient CRCs are integral to the safe and effective performance of clinical trials.</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com1tag:blogger.com,1999:blog-8278326853006166380.post-17679925809495554602014-10-13T04:31:00.000-07:002014-10-13T04:31:34.397-07:00KOL Management in Medical Writing and Research Solutions<div dir="ltr" style="text-align: left;" trbidi="on">
KOL is shorthand for Key Opinion Leader, a term used to categorize the professional doctors, medical service suppliers, and teachers who lead the medical group in improving better public wellness through research, posting, and medical practice.<br />
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As medication and life-sciences companies search for the most useful, good ways to handle cooperation with the doctors who perform research, create articles, or talk with deal with, connection control of the connections with these best doctors, or <a href="http://blog.worksure.org/kol-involvement-essential-for-healthcare-related-programs/">KOL Management</a> (KOLs), has eventually appeared as individual business self-discipline. Similar to CRM, KOL control is an important element for promoters and medical team right through the life-cycle process of a particular medication or product.<br />
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By beneath a company process that makes and preserves significant and collaborative connections between KOLs and company features from marketing to medical organizations, drug and life-sciences companies can information improved discuss of speech and multiplied adoptions at the international, nationwide, and local levels.<br />
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<b>Heart of KOL and <a href="http://blog.worksure.org/medical-affairs-services/">Medical Affairs Services</a></b><br />
As doctors do your best to choose from a numberless of medication options for their sufferers, they often turn to other key viewpoint innovator doctors for information and advice on certain medication. KOL Management enjoys a unique reliability, as their credibility often arises from years of market experience and medical connections. As a result, medication and life-sciences companies have started depending intensely on key viewpoint control to help set up the understanding about their medication and increase their marketplaces throughout all levels of life-cycle control.<br />
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<b>The Upcoming of KOL Management and <a href="http://blog.worksure.org/medical-writing/">Medical Writing</a> and Research Solutions</b> <br />
The effect of KOL on product or medication adopting is indisputable. Such as, the mutually beneficial, mutual relationship between a pharmaceutical or life-sciences company and its KOLs is important but critical to manage properly to maintain company and physician independence at every point. As medication and life-sciences companies keep catch the fantastic positive effect that KOLs have on their company, KOL management will keep growing and create as company behavior with training that could convert to key connections in other sectors.</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com24tag:blogger.com,1999:blog-8278326853006166380.post-50241077093996864242014-10-08T02:31:00.000-07:002014-10-08T02:36:11.680-07:00Medical Writing Training Course Benefits In Medical Data Management<div dir="ltr" style="text-align: left;" trbidi="on">
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Digital wellness information are very popular and in demand in healthcare methods these days. Many methods these days, such as <b><u><a href="http:/#">medical data management services</a></u></b> use this application for saving all their information.</div>
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There are a few individuals who are frightened about using electronic permanent healthcare record application for saving their healthcare information as they worry that it may contain insects that harm its performing and delicate information.</div>
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Then again, there are also many individuals who prefer choosing <a href="http://medical-affairs-management.blogspot.in/">Medical Affairs Management Services</a> for their electronic healthcare information as they feel there is nothing better than digital certification. This information is called EHR systems, where the best system offers various benefits over document healthcare information.</div>
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The main benefits are that it accelerates the individual certification procedure, such as their bills and medical concerns. Moreover, it makes sure the information is more precise as there is no chance of uncertainty going on in hand-written segments.</div>
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If needed, semi-automation is also used for boosting up the certification procedure. Moreover, healthcare methods that have electronic information provided by wellness information control solutions are much easier for the auditor to call up for appropriate information when they have to evaluate it. </div>
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It’s not practical to expect all your proper care needs to be taken proper at a single medical center. If you are known as another doctor to address your heart related illnesses, you have to take along your current healthcare information to show the new specialist. In situation of document information, the necessary records have to be recovered and couriered to the new location.</div>
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However in situation of electronic healthcare information, the facts can be safely and immediately sent to the new specialist. Or if needed, the doctors in other places can access the appropriate information available just by writing a security password and obtaining the wellness information control solutions network.</div>
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<strong>Helps preserve money</strong></div>
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Though smaller healthcare methods find it needless implementing EHR application, they can definitely benefit through wellness information control. They can preserve on document cash, choosing part-time employees to manage all this information and processing resources for all their document information. In fact, in some cases, individual privacy is also improved because of this as it’s difficult for electronic healthcare information to get lost or utilized by the wrong individuals. </div>
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While looking for the right wellness information control solutions for your healthcare office, choose something that’s easy for your employees to work and associate with. With the right solutions, everything related to payments, confirming and even invoicing because simple that allows improve your efficiency.</div>
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<strong>WorkSure™ MedPharma Consultancy India Pvt. Ltd. </strong>is a full <a href="http://www.worksure.org/pages/clinical-data-management-services.html"><strong>Clinical Data Management Services</strong></a><strong> </strong>(CDMS) based in New Delhi, India. Our main focus is to provide Data Management Plan, dcf generation, statistical analysis, medical coding services, <a href="http://blog.worksure.org/medical-writing/">medical writing</a> support to pharmaceutical, biotechnology and medical device companies.</div>
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com1tag:blogger.com,1999:blog-8278326853006166380.post-86352905956953935112014-10-07T03:45:00.000-07:002014-10-07T03:48:14.863-07:00Five Most Efficient Steps For KOL Management<div dir="ltr" style="text-align: left;" trbidi="on">
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For companies from the pharmaceuticals, biotechnology along with medical devices field, the existence along with role of <u><b>Key Opinion Leaders</b></u> (KOLs) is a matter of critical significance. To experience reliability out there and improve their own business, these creditors need to employ and set up successful connections with KOLs. This area of KOL control is relevant to CRM often. Just as businesses should fulfill the needs in their clients, it is also important to fulfill <a href="http://www.worksure.org/pages/medical-affairs-management.html">KOL Management</a> who is able to have a main effect in building a popularity and demand because of their items out there.</div>
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Optimal control of connections with KOLs is important for the success of your item. It is important kid recognize potential commanders before they acquire popularity and entire reliability, if an administrator can create a good relationship with a personal before they become an important figure in the career, this will create sure a strong connection. Here we have a look at 5 important methods effective KOL control might be assisted through the <a href="http://www.worksure.org/pages/clinical-data-management-services.html">clinical data management services:</a></div>
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<b>1 Alternative KOL profiles</b></div>
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CRM application is employed to draw out finished client details associated with targeted promotion. Furthermore, they point out leads and sales possibilities to create the most of. Supervisors can create use of this in KOL features by including particular information on important opinion leaders to build extensive KOL pages. With particular details at hand, one can plan particular techniques to deal with different KOLs. KOL store program will carry complete details regarding each KOL, from contact information to past record with all the organization and brand. An impressive CRM program will enable users to produce a main data source of guides, records, URLs and video clips connected to KOLs through the Material Collection. Admission to public details through public CRM is definitely an extra basically by allowing real-time use of content published basically by KOLs.</div>
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<b>2 Improve relationships</b></div>
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CRM application information personal information upon clients and choose this details available as and once needed. Furthermore, it can draw out connections in this particular information which may have been indecipherable otherwise. The similar can be used in KOL features. Every key opinion innovator will probably be handled on anyone foundation. This reduces an opportunity of connection mismanagement by creating the task much more effective. Factors such as changes out there and KOL might be outlined easily to create sure that these may be resolved on a positive foundation. Furthermore, the CRM remedy assures efficient activity features by guaranteeing open/ shut projects and prearranged sessions are available below appropriate information.</div>
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<b>3 Ensure company-wide adoption</b></div>
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CRM offer ideas to accomplish adopting of your specific system associated with handling KOLs throughout the organization. It is important experience a main data source of appropriate and important KOL details, which is often safely utilized basically by workers across almost all features from different places. From Marketing to research & Development, every function could require important home KOLs to create business choices. CRM alternatives furthermore accomplish creation of signals or administration guidelines to avoid several workers from calling the similar key opinion innovator.</div>
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<b>4 Determine relevant KOLs</b></div>
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One on the greatest advantages of CRM application is its potential to draw out only probably the most appropriate details, as and once needed. This can be very useful to eliminate all needless details while working with particular circumstances. Sometimes you might just need a targeted research on the KOL information to produce a precise decision. CRM provides the foundation for such research. In case of your particular drug or maybe item test, you can emphasize the relevant KOLs. This can especially work on times of problems to separate the key KOLs for that period.</div>
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<b>5 Evaluate real-time info</b></div>
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At the end on the day, the goal of KOL control should be to offer relevant details to appropriate men and women or positions every time needed. CRM application along with <u><b>KOL Management</b></u> features offer real-time reviews that may accomplish precise choice creating by quantifying along with collating details. For example, CRM reviews will help managers study specific reviews on all activities connected to KOLs for a particular period of your energy and effort with their relevant position along with due schedules.</div>
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Establishing and maintaining KOL connections might be complex, the least mismanagement can effect on the organization's qualifications so because of this on the need and adopting in their items. Applying a CRM answer increases KOL features and guarantees enhanced reliability for items and services.</div>
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com1tag:blogger.com,1999:blog-8278326853006166380.post-59154464622377188662014-10-04T06:16:00.000-07:002014-10-04T06:28:30.121-07:00Advantages of Clinical Data Management Services<div dir="ltr" style="text-align: left;" trbidi="on">
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Life sciences and healthcare expertise worldwide have reached at a stage where every individual gene and its functionalities are being researched. Currently the era is of methodical research and disciplined selection of information from sample research and testing of various examples ranging from microbiological to individual sufferers. Any scientific research needs many candidates and individuals, who can be studied, thus help create a data source that can be mathematically analyzed and information can be generated to come up with a precise solution for the topic under test. along with the lines of fingerprint scientific research forms a strong foundation that enables<span lang="EN-US"> <a href="http://www.worksure.org/" target="_blank">Clinicalresearch organization</a></span> to obtain vital information, mathematically analyze and identify individual traits that are undergoing phase tests depending on intrinsic and physical factors. </div>
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Clinical Data Management Studies is also called as CDMS, and as the name itself suggest the literal meaning of the term. Simply put, it means storage and maintaining information and information of sufferers.<br />
<a href="http://www.worksure.org/pages/clinical-data-management-services.html" target="_blank">Clinical data management services</a> is a system which helps to monitor health information and also the essential financial information of sufferers under study. Thus it saves a lot of manual workload and become a single data source which comprises of all the important information about the examples and topic that are under testing procedures. Biometrics information exploration is the method of finding the patient's information from the stored information, posing queries and extracting essential information from the data source to find a better and precise results pertaining to the research undertaken. The terms biometrics was basically correlated with research as fingerprint scientific tests were centered on selection of lots of mathematical information which was collected during different phases of drug development for healthcare illnesses. There are numerous scientific research companies that have initiated fingerprint scientific research solutions to provide a confined mathematical research and evaluating the effectiveness of drugs/medical methods in line to be commercialized.<br />
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To summarize healthcare information control shortens the time and energy required for carrying out elaborate scientific research process. The new protocols can be easily modified and included in the existing systems. CDMS along with biometrics information exploration is rapidly becoming more popular in many companies that undertake scientific research solutions.<br />
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With effective fingerprint scientific research and methodical approach during fingerprint scientific tests a CRO proudly gains an edge over its counterparts. India also has many centers offering fingerprint and healthcare information control solutions to attract big pharma companies to invest in them.
Worksure MedPharma Consultancy is dedicated to offering biometrics solutions internationally for Biometrics scientific tests, Biometrics scientific research and Biometrics information exploration.
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WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0tag:blogger.com,1999:blog-8278326853006166380.post-40233203170526077722014-09-12T04:27:00.003-07:002014-09-12T04:39:02.836-07:00WorkSure first medical service KPO in India - Your Medical Knowledge partner<div dir="ltr" style="text-align: left;" trbidi="on">
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<b><span style="background: yellow; font-family: Cambria, serif; font-size: 12pt;">“WorkSure, first medical service KPO in India, </span></b><a href="https://www.blogger.com/null" name="OLE_LINK6"></a><a href="https://www.blogger.com/null" name="OLE_LINK5"></a><b><span style="color: #31859c; font-family: "Cambria","serif";"> </span></b><b><span lang="EN-US" style="background: yellow; font-family: Cambria, serif;">Your
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<b><span style="background: yellow; font-family: Cambria, serif; font-size: 12pt;">is delighted to be chosen among the top 20
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WorkSure is the end to end
solution provider for Medical research ,Medical affair, Medico marketing,
Medical writing and Training. We work as medical knowledge partner to various
Pharmaceutical, Biotechnology, Medical Device Industries, CROs,
hospitals and even individual physician. We are a network of experienced
academicians, administrators and industry experienced professionals who have
come together to provide holistic services for the establishment and operation
of medical support function. Our team comprises of medical
postgraduates/specialist and PhDs <span lang="EN-US">having academic background from apex institutions of India like AIIMS,
PGIMER and IITs </span>with experience and expertise in various therapeutic
areas. <span lang="EN-US">We have robust
experience of working with leading Multinational & Indian companies, we
combine innovation and the finest technology available to meet our customer's
needs in sync with best industry practices.<b> <span style="color: #1f497d;"><o:p></o:p></span></b></span></div>
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<b><span lang="EN-US">We are based on cost elastic, high quality medical service model,
supporting organizations in customized budget<o:p></o:p></span></b></div>
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<b><span lang="EN-US">WorkSure would like to offer you specialized packages for our following
services: <o:p></o:p></span></b></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: Symbol; mso-ansi-language: EN-US; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><span lang="EN-US"><a href="http://www.worksure.org/pages/medical-writing-and-research-solutions.html" target="_blank">Medical Writing and Research Solution</a></span></b><span lang="EN-US">:<span style="color: #1f497d;"> </span>Serves
clients in terms of planning,<span style="color: #1f497d;"> </span>performing and
communicating research through preparation of various clinical, regulatory,
educational and promotional documents<span style="color: #1f497d;">.</span><o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: Symbol; mso-ansi-language: EN-US; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;"> </span></span><b><span lang="EN-US"><a href="http://www.worksure.org/pages/clinical-data-management-services.html" target="_blank">Clinical Data Management</a> (CDM)</span></b><span lang="EN-US">: <strong><span style="font-family: "Calibri","sans-serif"; font-weight: normal;">Provides a</span></strong><strong><span style="font-family: "Calibri","sans-serif";"> </span></strong>package for managing clinical data
from development of data management plan to its extraction for analysis and
final reporting, with supportive statistical and medical writing services.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: Symbol; mso-ansi-language: EN-US; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><span lang="EN-US"><a href="http://medical-affairs-management.blogspot.in/" target="_blank">Medical Affairs Management</a> (MAM)</span></b><span lang="EN-US">: Offers consulting services to marketing,
clinical trials, pharmacovigilance, regulatory and legal. <o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: Symbol; mso-ansi-language: EN-US; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><span lang="EN-US">Sales & Marketing Management (SMM):</span></b><span lang="EN-US"> Addresses the challenges in marketing and
sales by developing and designing promotional inputs to improve the visibility
of the product.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="font-family: Symbol; mso-ansi-language: EN-US; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><span lang="EN-US">Digital Marketing Management (DMM):</span></b><span lang="EN-US"> Takes into account online pharma marketing and
sales support products/tools, mobile applications, IPAD tools etc.<o:p></o:p></span></div>
<div class="MsoListParagraph" style="line-height: 115%; mso-list: l0 level1 lfo1; text-align: justify; text-indent: -18.0pt;">
<!--[if !supportLists]--><span lang="EN-US" style="color: #1f497d; font-family: Symbol; mso-ansi-language: EN-US; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><span lang="EN-US">Customer Relationship Management (CRM</span></b><span lang="EN-US">): Organizes Advisory boards, KOL management
& round table meetings.<span style="color: #1f497d;"><o:p></o:p></span></span></div>
<div class="MsoListParagraph" style="line-height: 115%; mso-list: l0 level1 lfo1; text-align: justify; text-indent: -18.0pt;">
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</span></span><!--[endif]--><b><span lang="EN-US">Clinical Education Management (CEM):</span></b><span lang="EN-US"> Conducts Continued Medical Education
programmes, medical training to the sales & marketing, medical &
research team. <b><span style="color: #1f497d;"><o:p></o:p></span></b></span></div>
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<br /></div>
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<b><span lang="EN-US">Please give us your valuable time so that we can discuss and explain our
services in person to meet you. We appreciate your time and concern for us and
hope to get positive reply.<o:p></o:p></span></b></div>
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<br /></div>
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<span style="position: relative; top: -3pt;">Please find the attached brochure for more information on our services.
You can also </span><span lang="EN-US" style="position: relative; top: -3pt;">visit our website </span><b><span lang="EN-US"><span style="color: black; mso-text-raise: 3.0pt; position: relative; top: -3.0pt;">www.worksure.org</span></span></b><span lang="EN-US" style="position: relative; top: -3pt;"> for more
detailed information,<o:p></o:p></span></div>
</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com2tag:blogger.com,1999:blog-8278326853006166380.post-59885684756955791052014-06-14T02:40:00.007-07:002014-06-14T02:53:07.378-07:00Clinical trials generate an extensive amount of statistical data<div dir="ltr" style="text-align: left;" trbidi="on">
<div class="separator" style="clear: both; text-align: left;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4-ODsLOQAQ07CRw4rWxyzI965AjlqXFI9RvS5GhkYFnJhUpYQYfVYIxop4BzOTxXZZq72zuobuIJPaxx_cmtuO9s8XHsk4Ub0UA1wMWyEfbk1ftGlmMZ1xk8G-u8P_32QPvp7Pl6onTU/s1600/wrorkpen.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4-ODsLOQAQ07CRw4rWxyzI965AjlqXFI9RvS5GhkYFnJhUpYQYfVYIxop4BzOTxXZZq72zuobuIJPaxx_cmtuO9s8XHsk4Ub0UA1wMWyEfbk1ftGlmMZ1xk8G-u8P_32QPvp7Pl6onTU/s1600/wrorkpen.jpg" height="320" width="116" /></a></div>
<span style="font-family: Calibri, sans-serif; font-size: 11pt; line-height: 115%;">Clinical trials generate an extensive amount of statistical data. With
the increasing complexity of segregated data collection, it is imperative to
have an effective system to manage and to statistically analyse the data to
produce end result. <a href="http://blog.worksure.org/clinical-data-management/" target="_blank">Clinical data management </a>system (CDMS) is used for this
purpose. Clinical data management (CDM) includes database entry, verification,
quality control and validation of the clinical trial data <b><span style="color: red;">Read More About <a href="http://blog.worksure.org/clinical-trails-drug-development-process/" target="_blank">Clinical Trails</a></span></b></span></div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0tag:blogger.com,1999:blog-8278326853006166380.post-39060538616579986802013-05-18T04:47:00.001-07:002013-06-24T23:34:29.184-07:00Medical Affairs Role in Pharmaceutical Companies<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj266wAvgkgBgugLC0sL7QLsXcvoI0sCQjBLzXQJND75ZY4AYl27M8w77fa15C6otu3A_FCN-7yaUYrqWXfqCzJQz-PHmlNZFyYkZ0-2Jc1D-rBVRvyB9l1kg3oMdo3hpx09sitz82RnVE/s1600/Medical+Affairs.gif" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" height="199" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj266wAvgkgBgugLC0sL7QLsXcvoI0sCQjBLzXQJND75ZY4AYl27M8w77fa15C6otu3A_FCN-7yaUYrqWXfqCzJQz-PHmlNZFyYkZ0-2Jc1D-rBVRvyB9l1kg3oMdo3hpx09sitz82RnVE/s200/Medical+Affairs.gif" width="200" /></a></div>
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The Medical affairs groups are a growing vital sector in
today's bio pharmaceutical industry in providing hospital consultants, key
opinion leaders (KOL's), regulatory agencies and healthcare professionals with
scientific and medical information relating to the value and correct usage of the
products. </div>
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<a href="http://www.worksure.org/" target="_blank">Medical affairs</a> personnel strive for the highest scientific
integrity so as to produce successful <a href="http://www.worksure.org/" target="_blank">clinical trials</a> and supply the greatest
support for the market. Medical affairs groups perform many activities often
overlapping with sales, Medical marketing, clinical growth, and customer
service. </div>
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Sales groups may be ill-positioned to accurately present the
new product to physicians and quite often need help in making more expert
presentations. Medical affairs groups might help in developing appropriate
positioning for new releases and help to leveraging the newer indications to
come.</div>
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Pharmaceutical companies spend tremendous resources for
development of new drug treatments. A great deal of time is spent in doing
research on potential health-related products and medicines. </div>
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While considering the distinctions between post marketing
scientific tests and clinical registration demos, medical affairs can fill the
requirement for the studies done post approval. </div>
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<b style="mso-bidi-font-weight: normal;">Medical Affairs Role
in Functional Areas:</b></div>
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Medical Affairs acts as the central focal point for
different therapeutic areas of sales, marketing and research. Medical Affairs
work closely with various functional departments such as:</div>
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<b style="mso-bidi-font-weight: normal;">Medical Writing</b></div>
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Scientific Development and Reviewing connected with Product
profiles, monographs, package deal insert/ patient information booklet,
pharmacology and toxicology parts of registration dossiers with constant
updates.</div>
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<b style="mso-bidi-font-weight: normal;">Preparation of
Professional medical Development Plan</b></div>
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Providing therapeutic and scientific content for development
of study standard protocol</div>
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Designing and implementation connected with pharmacoeconomic
studies</div>
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Reviewing along with approval of regulatory submission,
manuscripts, abstracts, posters as well as other scientific documents.</div>
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<b style="mso-bidi-font-weight: normal;"><span id="goog_1296810125"></span>Medical Monitoring:<span id="goog_1296810126"></span></b></div>
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Medical affairs are the Primary medical contact towards the
sponsor, investigative website, and project group.</div>
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Medical Affairs supports the look, conduct and evaluation of
clinical research and involves continuous data maintenance as well as
management.</div>
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Involves in talk on study feasibility together with Key
Opinion Leaders as well as other potential investigators with regards to
possible logistical requirements of the study protocol as well as responds to subject
eligibility and disengagement questions.</div>
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A Medical affairs team is usually responsible for Medical
Monitoring:</div>
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Medical affairs are the Primary medical contact towards the
sponsor, investigative website, and project group.</div>
<div class="MsoNormal">
Medical Affairs supports the look, conduct and evaluation of
clinical research and involves continuous data maintenance as well as
management.</div>
<div class="MsoNormal">
Involves in talk on study feasibility together with Key
Opinion Leaders as well as other potential investigators with regards to
possible logistical requirements of the study protocol as well as responds to
subject eligibility and disengagement questions.</div>
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A Medical affairs team is usually responsible for clinical
trials Protocol and study linked training for researchers and site personnel.</div>
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<a href="http://worksure.wordpress.com/2013/03/19/medico-marketing/" target="_blank"><b style="mso-bidi-font-weight: normal;">Medico Marketing:</b></a></div>
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During Pre launch cycle of drug the actual Medical Affairs
team will establish a KOL strategy for this product based upon prescriber's
interest in research and education for your given indication. Then MA
departments will target prospective KOLs and connect to them regarding the
actual science behind the revolutionary product, ongoing trials like the
balanced information regarding both positive along with negative results. Also
discuss the important thing data from healthcare meetings and summaries of
changes to apply the guidelines. In addition it will conduct additional
education activities of Sales/Marketing individuals to raise awareness of the
disease state, current therapeutics, and current gaps in sufferer care.
Further, the interests of the KOLs will be assessed during discussions to find
out the appropriate scientific exchange and any prospective opportunities for
potential investigator-initiated trials (IITs).</div>
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At the time of product launch MA was responsible in ensuring
clear understanding on utilization of the product by the prescribers. They
exchange technological information regarding compound-specific characteristics
and physician perceptions of the drug profile. In those times MA will perform an
evaluation of IIT proposals that might generate a Step IV strategy which will
further differentiate the merchandise post-marketing.</div>
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During the Post-launch period of a drug, MA seeks
suggestions from KOLs and along with this, it resolves the queries regarding
the product ensuring that they know exactly how you can use the product or
service. MA maintains the collection of information regarding the acceptance of
the product among prescribers along with issues being confronted by the drug.
These valuable data will update marketing work as deemed necessary. Further
discussions upon clinical practice roles and potential extra indications with
KOL's facilitate the commencement regarding IITs and Step IV studies. </div>
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<b style="mso-bidi-font-weight: normal;">Conclusion: </b></div>
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Medical Affairs is the majority of credible link with
external stakeholders and also play a progressively more important role in
communicating the product or service value message to physicians in an
objective and ethical manner. They provide assistance in dissemination of
technological information regarding current products to regulating agencies and
healthcare professionals. Thus Medical Affairs play an important role in
establishing appropriate positioning for new items and help to<span style="mso-spacerun: yes;"> </span>help leverage the newer indications in the
future.</div>
</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com4tag:blogger.com,1999:blog-8278326853006166380.post-26967909289423255372013-04-25T23:44:00.001-07:002013-04-26T22:21:55.383-07:00ESSENTIALS OF MEDICAL WRITING<div dir="ltr" style="text-align: left;" trbidi="on">
Professional medical writing involves communication of clinical and scientific data in the form of research and regulatory paperwork, articles for publication, in addition to content development for health-related publications, pharmaceutical companies and professional medical websites. The nature of medical writing varies using the need of the end user; for example documents regarding medical journals, physicians, individuals, pharmaceutical companies etc.<br />
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A capable Medical Writer must have good understanding of life science, medical and pharmaceutical terms along with proper knowledge of The english language. Qualities of a simple yet effective Medical Writer comprise of correct interpretation of target audience needs, better perception of project objectives, ability to prepare thoughts and deliver inside stringent timelines.<br />
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<a href="http://www.worksure.org/" target="_blank">Medical writing</a> gets started with appropriate literature seek and identification of reliable cause of information. In order to develop and frame an original work it truly is obligatory to apprehend the topic well by thorough literature review. Moreover, fact presentation in any scientific article is justified judging by genuine references, which makes literature search much more important.<br />
Literature search ends up by having an unorganized pile of raw material which should be shaped and constructed in a order. There must be cohesion among sentences those must grow and count on each other, thus building logically correlated paragraphs. Such glued paragraphs are designed for conveying the medical author ideas effectively, whereas any non-cohesive mass of sentences leaves the reader mixed up and frustrated. The principle of cohesion with medical writing is that the sentences must provide linear move of information making file appealing and interesting for you to reader.<br />
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A careful selection in addition to elimination of data in addition to information from collected material is essential. A good medical writer should not stray from the subject. Content must be educational, well-constructed and correlated to hold the reader curious all through. A skillful assemblage of facts is necessary to guide the reader over the write up from what he knows as to the he wants to know in accordance to his needs in addition to expectations.<br />
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Medical Writer must allow you to assembling the draft inside a proper format, with apparent and precise explanation shown without ambiguity. Once a draft is prepared it truly is revised repeatedly to make it more comprehensible, communicative in addition to revealing. Medical writer should be capable of comprehend the prerequisites of varied types of articles one example is research article, original post, systematic review, brief record, editorial, case reports, in addition to letter to editor. Along with manuscript preparation, an effective Medical Writer should develop the skills to ascertain the high quality (based upon factors like impact factor and different indexes or rankings) and choice of journals. A clear check out of journal specific requirements is equally important. On top of that, medical writing includes prep of write ups regarding conferences; promotional items for marketing and sales team and training material.<br />
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Other attributes of your competent Medical Writer include presentation in the data in accordance for you to client’s requirement or predefined SOPs and most crucial of all is usually to avert plagiarism.<br />
There is a significant need for efficient Medical Writers in drug companies, biotech organizations, nursing homes, contract research organizations (CROs) as well as other health communication agencies. The particular ever changing world of clinical and scientific study demands continuous propagation of technical knowledge. Medical writing is a compelling demand of contemporary scientific world.<br />
<br />
<a href="http://www.worksure.org/" target="_blank">WorkSure™</a> provides a wide range of high quality <a href="http://www.worksure.org/" target="_blank">Medical Writing Services</a> for pharmaceutical, biotech and medical devices companies. Our team of qualified and experienced medical writers helps you bring out a wide range of regulatory, clinical, scientific and marketing communication documents allowing you to focus on your core competency areas.</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com2tag:blogger.com,1999:blog-8278326853006166380.post-45925559528638548092013-03-19T00:44:00.000-07:002013-04-26T22:24:44.556-07:00Medical marketing shall avoid misleading advertisements and disease mongering<div dir="ltr" style="text-align: left;" trbidi="on">
Medico advertising and marketing consists of campaign associated with <a href="http://www.worksure.org/" target="_blank">pharmaceutical</a> drug products. It allows for for you to consistently bring up to date medical professionals, the medical staff in addition to pharmacists concerning the safe and effective utilization of medicines. <a href="http://www.worksure.org/" target="_blank">Medical marketing</a> involves routines by simply medicos or even organizations for you to actualize areas regarding pharmaceutical drug treatment.<br />
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The entire world Health Organization defines pharmaceutical drug campaign because “all information in addition to influential routines performed by simply pharmaceutical drug makers in addition to suppliers, attempting to have an impact on your health professional prescribed, offer, purchase, and/or utilization of professional medical drugs”.<br />
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The actual achievement associated with medico advertising and marketing depends upon your approaches or even strategies adopted regarding advertising and marketing. A powerful advertising and marketing operations depends upon method associated with objectives, identification of any market you work in, possessing a plan to own objective in addition to evaluation associated with marketing strategy at standard time periods regarding examining your improvement.<br />
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Pharmaceutic firms utilize a pair of water ways associated with advertising and marketing tactics: 1) push flow in addition to 2) pull flow. Thrust flow technique goals for you to influence conclusion maker’s (physician’s) health professional prescribed habits through marketing such things as detailing, substance sample, record content articles, record marketing, management meetings, professional medical meetings and so forth. Yank flow technique is usually precise on end people in addition to pressurizes medical professionals for you to suggest a certain substance according to patient’s obtain.<br />
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Advertisements are crucial regarding examining home elevators medicines for you to medical professionals and are also trusted by simply pharmaceutical drug firms regarding campaign of their products. Info offered with adverts needs to be associated with premium quality in addition to must not be incorrect or even do not forget that. Advertisements which in turn exaggerate the benefits of medicines in addition to usually participate in decrease possibility linked to drug treatments, can result in possible unwanted side effects. Health professionals pursuing this sort of marketing information may jeopardize existence on the affected individuals by simply recommending unreasonable drug treatments. Therefore, pharmaceutical drug firms should steer clear of unethical medico advertising and marketing practices including mistaken adverts in addition to illness mongering.<br />
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The actual medico advertising and marketing office associated with almost any pharmaceutical drug organization should stick to 3 main limitations:<br />
1) The worldwide Federation associated with Pharmaceutic Manufacturers (iFPMA) rule associated with pharmaceutical drug advertising and marketing practices<br />
2) The globe Health Organization’s honourable requirements regarding therapeutic substance campaign<br />
3) The rule served by Health Action Worldwide<br />
<br />
<a href="http://www.worksure.org/" target="_blank">WorkSureTM</a> concentrates on <a href="http://worksure.wordpress.com/2013/03/19/medico-marketing/" target="_blank">Medico-marketing</a> in addition to Health-related Extramarital liasons Managing in addition to assist business to honourable merchandise campaign.</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com1tag:blogger.com,1999:blog-8278326853006166380.post-13162243530109614122013-03-05T23:17:00.002-08:002013-03-25T22:21:55.306-07:00Investigational Medicinal Product Dossier<div dir="ltr" style="text-align: left;" trbidi="on">
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<div class="MsoNormal" style="text-align: justify;">
<a href="http://www.worksure.org/" target="_blank">Clinical Trial Authorization</a>
(CTA) is compulsory to conduct medical tests in people. CTA can only be
acquired after submission of a number of medical records in the type of
Investigational Medicinal Products Dossier (IMPD). EU Medical Tests Instruction
2001/20/EC describes “<a href="http://www.worksure.org/index.php" target="_blank">Investigational medicinal product</a>” (IMP) as, “A
medication way of an effective material or sugar pill being examined or used as
a referrals in a medical trial, such as products already with a promotion
authorization but used or constructed (formulated or packaged) in a way
different from the approved type, or when used for an illegal sign, or when
used to obtain further details about the approved type. IMPD is ready for
obtaining CTA for an IMP and its use in the medical trial, such as details
about referrals products and placebos. Apart from this, information from
nonclinical research and past facts of medical use of IMP is required in IMPD
and if such detail is missing, justification for the same should be offered in
the program. IMPD can be of two types: a complete IMPD and a simple IMPD.</div>
<div class="MsoNormal" style="text-align: justify;">
A complete IMPD is needed if no
before distribution of any details about the substance or medical item is
created to the qualified power and in situations when information cannot be mix
known. A complete IMPD should integrate summaries of details regarding
excellent, produce and management of the IMP along with non-clinical and
medical information such as creature pharmacology and toxicology research,
previous reports of medical trial and individual experiences with the item,
overall danger and advantage evaluation. Usually, the dossier should not be
huge papers, even though exclusions may happen. Data should be offered in
tabular type along with brief information featuring everything.</div>
<div class="MsoNormal" style="text-align: justify;">
A simple IMPD is sufficient if
all necessary details relevant to the IMP had been formerly analyzed as aspect
of a promotion authorization in any nation or as part of Clinical Trial
Authorization (CTA) to the concerned Competent Authority. The material must
contain a conversation about the danger and advantages of suggested trial.
Summary of item features (SmPC) maybe used as IMPD in situations where IMP has
a Marketing Permission in any EU Participant Condition and is being used in the
same type, for the same sign and with a dosing routine protected by the SmPC.</div>
<div class="MsoNormal" style="text-align: justify;">
As per “Checklist for programs
for allow of acceptance of various groups of New Drug, International Medical
trial and Bioequivalence research for trade purpose” by CDSCO (Central
Medication Conventional Control Organization), the IMPD is essential for
“Application of International Medical Trial” in Indian.</div>
</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com1tag:blogger.com,1999:blog-8278326853006166380.post-71173081540938288282013-01-25T23:05:00.000-08:002013-01-25T23:07:00.889-08:00Clinical Trial Application (CTA) submission in India<div dir="ltr" style="text-align: left;" trbidi="on">
<br />
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-layout-grid-align: none; text-align: justify; text-autospace: none;">
<span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: Arial;">A
Clinical Trial Application (CTA) is submitted to regulatory authority (Drugs
Controller General of India) to seek approval for conduct of a clinical trial
in India. </span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: ArialMT;">Form 44 is an application made for grant of
permission to import or manufacture a new drug or to undertake Clinical Trial.</span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: Arial;">
The trial sponsor has to submit the application (Form 44) and</span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: ArialMT;">
documents pertaining to chemical and pharmaceutical information, animal
pharmacology, toxicology data and clinical pharmacology data. </span><a href="http://www.blogger.com/blogger.g?blogID=8278326853006166380" name="OLE_LINK2"></a><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: Arial;">Other
trial-related documents that must be submitted for approval include the
Investigator’s Brochure, trial protocol, case report form, informed consent
form, patient information sheet, investigator’s undertaking and IEC approvals (if
obtained during review process). Regulatory
status of the trial in other participating countries also needs to be reported.
Additional requirements exist for studies in special populations, e.g.,
children, pregnant women, nursing women, elderly patients, patients with renal
or other organ system failure, and those on specific concomitant medication(s).
</span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: ArialMT;"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-layout-grid-align: none; text-align: justify; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-layout-grid-align: none; text-align: justify; text-autospace: none;">
<span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: ArialMT;">Submission
of clinical trial applications have been </span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: Arial;">classified
into two categories: A and B since 1st December 2006. Category A trial submission
comprises of protocols which have been approved by EMEA or regulatory
authorities in US, UK, Japan, Australia, Canada, Germany, Switzerland or South
Africa. The projected timelines for approval of Category A application is around
two to four weeks. Category B trial submission undergoes the standard review
process by expert committee and the turnaround time for approval is about eight
to twelve weeks. An impediment in approval timelines occur in case of incomplete
applications or due to delay in resolution of queries by the sponsor. If a submission is made under category B and
later approvals are sought from a Category A country still the submission
category cannot be modified. Review period may also get prolonged if Drugs Controller
General of India (DCGI) requests assistance from Indian Council for <a href="http://www.worksure.org/pages/medical-writing-and-research-solutions.html" target="_blank">Medical Research</a> (ICMR) or Department of Biotechnology (DBT) based on the application.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-layout-grid-align: none; text-align: justify; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0cm; mso-layout-grid-align: none; text-align: justify; text-autospace: none;">
<span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: ArialMT;">We
at WorkSure™ support in preparation of </span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: Arial;"><span id="goog_1514511664"></span>Clinical
Trial Application<span id="goog_1514511665"></span> and related documents viz. Investigator’s Brochure, trial
protocol, case report form, informed consent form, patient information sheet,
EC submission document etc. WorkSure</span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: ArialMT;">™</span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: Arial;"> also
provides technical expert representation to undertake discussions with
regulatory authority.</span><span lang="EN-US" style="font-size: 12.0pt; line-height: 150%; mso-bidi-font-family: ArialMT;"><o:p></o:p></span></div>
</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0tag:blogger.com,1999:blog-8278326853006166380.post-89223648410069110932012-12-22T08:42:00.002-08:002012-12-22T08:42:49.936-08:00Medical Service KPO: An offshoot of Healthcare KPO<div dir="ltr" style="text-align: left;" trbidi="on">
Knowledge Process Outsourcing (KPO) is a higher-end version of outsourcing business processes that require significant domain expertise. Thus KPO emphasizes on services based on knowledge power. At present, major categories of domain knowledge that are working as KPO include legal process, research and development, market research, financial services research, business intelligence and medical services.<br />
<br />
Medical service KPO is a health care KPO, which, identifies and addresses the met and unmet medical needs associated with products, therapies and disease states in order to drive improvement in patient outcomes. It performs highly complex and structured medical/scientific tasks which necessitate analytical and technical skills along with vital judgemental abilities. Services of a medical service KPO include research & medical writing, clinical data management, medical affairs management, medical based marketing & sales support and training. A proficient medical service KPO team comprises of highly qualified (medical postgraduates and PhDs) and skilled workforce with experience and expertise in various therapeutic areas. The team should have high levels of intellectual property and business knowledge sensitivity. <br />
<br />
Currently pharmaceutical/biotechnology companies are facing a lot of challenges viz. increasing research & development costs, unavailability of blockbuster molecules, pricing pressures as well as increased overheads. At this juncture, outsourcing of high-end processes to third party is a viable option. The major strength of this approach is not the cost-saving aspect but the more value that these services provide. A medical service KPO not only supports pharmaceutical, biotechnology and medical device industries but also hospitals, CROs and other healthcare sectors. Medical service KPO also assists healthcare fraternity to undertake and publish research projects. Thus they promote medical research at the level of individual physician, as well as hospitals; conduct training in medical research methodologies; assist in developing research plans; managing, analyzing and interpreting data, and even communicating medical research on various platforms and journals.<br />
<br />
An early driver of medical service outsourcing is the shortage of skilled manpower. Companies face unavailability of trained and specialized professionals in this knowledge-intensive, high-skill sector of medical support function. Also developing and sustaining an in-house team of highly technical medical professional is costly and drain lot of money and efforts of training. WorksureTM, a first <a href="http://www.worksure.org/" target="_blank">medical service KPO in India</a>, works as medical knowledge partner to various health care industries and even individual physicians. They are a network of highly qualified and experienced academicians, administrators and industry experienced professionals who have come together to provide holistic services for the establishment and operation of medical support function.<br />
<br />
Domain expertise, language skills, knowledge of regulatory framework, innovative processes and quick response time have led to efficient service delivery and growth of WorkSureTM as <a href="http://www.worksure.org/" target="_blank">medical service KPO</a>. WorkSureTM understand the importance of training and skill development, especially at the entry level. In addition to project-specific training, it focuses on developing soft skills and behavioural aspects to help the employees become more productive in their work. WorkSureTM, first medical service KPO in India has a vision to promote medical research through model of cost elasticity, provide continuous education and learning opportunities to practising medical fraternities, pharmaceutical/biotech/medical device industries and increase emphasis on ethical medical/promotional communication.
</div>
WorkSure MedPharma Consultancy India Pvt. Ltd.http://www.blogger.com/profile/08108519806001133183noreply@blogger.com0