ESSENTIALS OF MEDICAL WRITING

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.

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.

Medical writing 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.
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.

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.

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.

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.
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.

WorkSure™  provides a wide range of high quality Medical Writing Services 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.

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Medical marketing shall avoid misleading advertisements and disease mongering

Medico advertising and marketing consists of campaign associated with pharmaceutical 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. Medical marketing involves routines by simply medicos or even organizations for you to actualize areas regarding pharmaceutical drug treatment.

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”.

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.

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.

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.

The actual medico advertising and marketing office associated with almost any pharmaceutical drug organization should stick to 3 main limitations:
1)    The worldwide Federation associated with Pharmaceutic Manufacturers (iFPMA) rule associated with pharmaceutical drug advertising and marketing practices
2)    The globe Health Organization’s honourable requirements regarding therapeutic substance campaign
3)    The rule served by Health Action Worldwide

WorkSureTM concentrates on Medico-marketing in addition to Health-related Extramarital liasons Managing in addition to assist business to honourable merchandise campaign.

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Investigational Medicinal Product Dossier

Clinical Trial Authorization (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 “Investigational medicinal product” (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.

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.

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.

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.

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Clinical Trial Application (CTA) submission in India

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. Form 44 is an application made for grant of permission to import or manufacture a new drug or to undertake Clinical Trial. The trial sponsor has to submit the application (Form 44) and documents pertaining to chemical and pharmaceutical information, animal pharmacology, toxicology data and clinical pharmacology data.  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).

Submission of clinical trial applications have been 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 Medical Research (ICMR) or Department of Biotechnology (DBT) based on the application.

We at WorkSure™ support in preparation of Clinical Trial Application and related documents viz. Investigator’s Brochure, trial protocol, case report form, informed consent form, patient information sheet, EC submission document etc. WorkSure™ also provides technical expert representation to undertake discussions with regulatory authority.

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Medical Service KPO: An offshoot of Healthcare KPO

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.

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.

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.

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 medical service KPO in India, 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.

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 medical service KPO. 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.

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Pre-clinical and clinical research: Part of drug development process

Preclinical development
Pharmaceutical research plays an essential role in the development of new drug molecules for safe and effective use in patients. Pre-clinical and clinical research is two important phases in drug discovery and development process. It takes about 12 to 16 years to bring a molecule from laboratory to clinical practice. Based on the type of drug molecule, the duration of pre-clinical research varies from 2 to 6 years while clinical research takes approximately 7 to 12 years. Today the challenge with pharmaceutical research is to reduce the lead time of pre-clinical and clinical phases, which can be made possible by adopting newer technologies, using rational drug design process in place of traditional processes.

Pre-clinical research is combination of in vitro, in vivo and ex vivo experiments before the clinical trials. Target identification, target validation, lead identification, lead optimization and finally synthesis of the new drug molecule for a specific disease are important steps of pre-clinical research. After the synthesis of a drug molecule, different tests and experiments are done in laboratory and animal models for the collection of safety and efficacy information for the clinical trials. The primary objective of pre-clinical research is identification of physiological, toxicological and efficacious potential of drug molecule. Study of pharmacodynamics, pharmacokinetics, immunogenicity, immunotoxicity, developmental toxicity, genotoxicity studies and carcinogenicity properties with identification of initial safe dose, target organs and other safety parameters constitute secondary objectives. Regulatory authorities wants to minimise the use of animals in pre-clinical trials due to animal rights issues, so

selection of animals for the pre-clinical trials is another important aspect, normally one rodent and one non-rodent species are used for the same. High quality safety and efficacy data is required by the regulatory authorities before giving approval for conduct of clinical trials in humans in the form of IND (New Drug Application) submission.

Phases of Clinical development
Clinical research determines the safety and efficacy of medications, devices, diagnostic products and treatment regimens discovered for the human use in terms of prevention, treatment, diagnosis or for relieving symptoms of a disease. Successfulness of the pre-clinical research and approval from the regulatory authority are the mandatory requirements for the clinical trials. Clinical trials are divided in 4 phases from phase 1 to 4

Phase 1 clinical trials commonly known as human or clinical Pharmacology trials, first phase of clinical trials conducted in small group of healthy human volunteers (20-100). In this phase the medicinal product is administered first time in human body for identifying pharmacokinetic (absorption, distribution, metabolism, excretion and liberation) properties of drug. The main objective of phase 1 clinical trial is to assess the safety data and safe-dosing range of a drug.

Phase 2 clinical trials commonly known as therapeutic exploratory trials, performed on larger groups (100-300) after the establishment of initial safety of the study drug in Phase 1 clinical trials. The main objective of this phase is to collect the data for effectiveness and safety assessments in patients. Sometimes phase 2 trials are divided into: phase 2a trials and phase 2b trials. Phase 2a trials, commonly known as pilot trials, collect information about pharmacodynamic (dose-response, type of patient, frequency of dosing and find any other issues related to safety and efficacy) properties of drug in patients. Phase 2b trials commonly known as pivotal trials are well-controlled trials to evaluate safety and efficacy in large number of diseased subjects (500-1000), represent the most rigorous demonstration of efficacy.

Phase 3 clinical trials commonly known as therapeutic confirmatory trials usually involves 1,000 to 5,000 patients in multicentric setups. The main objective of this phase is to confirm safety, efficacy and identify adverse events related to drug molecule. Sometimes phase 3 trials are divided in 2 groups: Phase 3a trials and Phase 3b trials. Phase 3a trials are conducted before the new drug application (NDA) submission to the regulatory to generate additional data on safety and efficacy in relatively large numbers of patients in both controlled and uncontrolled trials. Phase 3b trials sometimes called as peri-approval trials are conducted after NDA submission to the regulatory but before the approval of marketing of the drug. Phase 3b trials may supplement earlier trials, complete earlier trials, or may be directed toward new types of trials (e.g. quality of life, marketing) or Phase IV evaluations.

Phase 4 trials commonly known as post-marketing surveillance, takes place after obtaining marketing approval for the drug. Phase IV trials involves the pharmacovigilance and technical support for the patients and medical professionals. The main objective of these trials is to set up, evaluate and collect long-term safety data for the drug in the form of PSUR (periodic safety update report) as a requirement of regulatory authorities.

Apart from these main 4 phases of clinical trials, 2 other phases of clinical trials - phase 0 and phase 5 - have been recently introduced in the field of clinical research, based on type of the drug or molecule. Phase 0 clinical trials are commonly known as micro-dosing trials, a very small dose of investigational drug is given to the healthy voluntears for the study of efficacy, toxicity and pharmacokinetic properties. Phase 5 clinical trials are also a type of post-marketing surveillance to study the comparative effectiveness research in a specific community or populations.

We at worksure provide all the solutions for the pre-clinical and clinical research, in terms of trial related document (Protocol, CRF, Investigator brochure, ICF & other)preparation, editing & review of sponsor prepared documents, investigator meetings & study result meetings arrangements, SOP preparation, developing QA/QC plan, clinical study reports prepration, abstracts and publication writing, poster/PPTs prepration for conferences and meta-analysis/systematic review prepration. We also provide regulatory solutions and clinical data management services for the clinical trials.

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Understanding Pharmacovigilance System & Processes

According to WHO “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” In other words the goal of pharmacovigilance is getting the best outcome of therapy by patient care and surveillance. Good pharmacovigilance will identify the risks and risk factors related to adverse drug reactions (ADRs) during the complete product life cycle. This information allows for intelligent, evidence-based prescription and has the potential for preventing ADRs.

The importance of Pharmacovigilance

The primary aim is to enhance patient safety and to provide reliable and balanced information for the effective use of medicines. The secondary aim is communication of new safety ?ndings to the national and international regulatory authority in a timely manner. Pharmacovigilance programmes promote the education and training in this field and its effective communication to the public. Pharmacovigilance identify adverse events and their rates with the possible risk factors. It assesses causality with respect to clinical relevance, frequency and distribution of ADRs, which helps to understand the benefit, harm, effectiveness and risk of medicines.

Good Pharmacovigilance Practice

The concept of pharmacovigilance is normally not well understood, either by health professionals, patients or the general population. Development of guidelines and standards are required for a coherent and good pharmacovigilance system, which describe the practical details of the intended information Now.

Good pharmacovigilance systems should have the capability for receiving and processing of reports with veri?cation, interpretation and case causality assessment. It should have databases and procedures for data analysis, review and signal detection. An effective coordination between health care settings, regulatory and public health activities is required. Also regular training of health care workers in reporting adverse reactions improves both active and passive reporting.

Spontaneous reporting is a system whereby case reports of adverse drug events are voluntarily submitted by health professionals, pharmaceutical companies or consumers to the national pharmacovigilance centre. It is basically the reporting of a suspected adverse reaction on the initiative of the health professional that becomes aware of the problem, or on the patient’s initiative. Cohort event monitoring refers to the use of prospective, observational cohort studies of patients to whom the medicine of interest has been administered with recording of all adverse events.

Pharmacovigilance system may be run by a person or group of persons with expert knowledge of drug safety and adverse events under the independent government setup. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopeia commission is initiating a nation-wide pharmacovigilance programme for protecting the health of the patients by assuring drug safety. The programme shall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The centre will operate under the supervision of a Steering Committee.

We at WorkSure provide complete Pharmacovigilance system and Process solutions for signal detection, signal evaluation, medical review and causality assessment of safety data (AEs, SAEs, SUSARs etc). We also provide medical writing services for preparation of safety reports eg ICSRs, PSURs etc as per regulatory requirements, and resolving queries from regulatory authorities on safety issues.

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