Clinical Trial and Complete Clinical Data Management by WorkSure

 #WorkSure offers Clinical trial & Complete clinical data management services with Structured and scientific approach to protocol designing, development of a data management plan, health outcome analysis, final reporting, statistical and medical writing support.

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Read More at: https://www.worksure.org/pages/clinical-trial-clinical-data-management/

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WorkSure one stop guide for Medical Writing service

Medical writing 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. Medical writing 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.

Medical writing 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.

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.

WorkSure™ MedPharma Consultancy (WMC), 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.

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, pharmacovigilance & coaching.

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 Clinical Trial Program (CTA), Investigational Therapeutic Product File (IMPD), Investigational New Medication (IND) & New Medication Program (NDA), medical information alternatives and KOL control.

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.

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 Clinical Research Companies setting new requirements in this field.

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Medical writing and Regulatory Affairs from WorkSure

WorkSure A First Medical Service KPO in India 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.
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.
WorkSure direct interaction with Regulatory Affairs, 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.
Why outsource to WorkSure?

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.
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 (Regulatory Affairs, Pharmacovilance, Medical Writing, Research Solutions, Pre-clinical and Clinical Trials) and as the need be.

How outsourcing can be a useful activity?

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.
c) Commitments for a limited period and do not require to you recruitment an internal personal.
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.
Regulatory Affair Services

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.
The primary services include

Medical consultant representation at National Regulatory Authority meetings
Preparation of Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND) & New Drug Application (NDA)
Render support for preparation of medical device submissions eg 510(k) and pre-market approval documentation.
Risk Management Plan / REMS (Risk Evaluation and Mitigation Strategies) and other regulatory documents for clinical trial and drug marketing approval.
Preparing prescribing information, product monographs and product labeling

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.

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WorkSure first medical service KPO in India - Your Medical Knowledge partner

“WorkSure, first medical service KPO in India,  Your Medical Knowledge partner”

is delighted to be chosen among the top 20 promising pharma business solution companies [CIO review Aug. 2014]”

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 having academic background from apex institutions of India like AIIMS, PGIMER and IITs with experience and expertise in various therapeutic areas. 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.

We are based on cost elastic, high quality medical service model, supporting organizations in customized budget

WorkSure would like to offer you specialized packages for our following services:

·         Medical Writing and Research Solution: Serves clients in terms of planning, performing and communicating research through preparation of various clinical, regulatory, educational and promotional documents.

·     Clinical Data Management (CDM): Provides a 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.

·         Medical Affairs Management (MAM): Offers consulting services to marketing, clinical trials, pharmacovigilance, regulatory and legal.

·         Sales & Marketing Management (SMM): Addresses the challenges in marketing and sales by developing and designing promotional inputs to improve the visibility of the product.

·         Digital Marketing Management (DMM): Takes into account online pharma marketing and sales support products/tools, mobile applications, IPAD tools etc.

·         Customer Relationship Management (CRM): Organizes Advisory boards, KOL management & round table meetings.

·         Clinical Education Management (CEM): Conducts Continued Medical Education programmes, medical training to the sales & marketing, medical & research team.

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.

Please find the attached brochure for more information on our services. You can also visit our website www.worksure.org  for more detailed information,

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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 Writing

Medical writing, an integral part of medical research and communication, can be defined as an art of creating scientific documents with the aim of transmitting information of technical nature in lucid and simple manner to health care professionals, scientific community, general public and patients. Target audience needs normally define the pattern of medical writing. The language for medical education of Physician/healthcare professional has to be highly technical while simple and lay communications are required to connect with general public or patients. There is a significant need for medical writing in pharmaceutical and biotechnology companies, contract research organizations (CROs) and other health communication agencies. WorkSure™ medical writing team supports an umbrella which includes scientific writing for marketing promotions, sales team training and education, medical education, patient and public education, medical research and regulatory communications. Any writing goes through a stringent medical review process for quality control and to prevent plagiarism.

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