Medical writing is a quintessential form of scientific writing where the scientific information of the research performed by the scientists/researchers is documented and presented for the understanding of a set of audience. Medical writing is a very specialized and technical process and therefore requires a thorough understanding of the medical and scientific terminology. The target audience may be healthcare professionals such as physicians, pharmacists, nurses, etc., researchers, pharmaceutical organizations, regulatory authorities and even the patients or general public. The flow of information is the primary requirement from researchers to the regulatory authorities and from pharmaceutical companies to physicians or other healthcare professional or to the patients. Medical writing acts as a major mode of communication for the on-going pharmaceutical research, the recent advancements and the regulatory guidelines. The contents of medical writing are in the form of articles for publications, documents for medical journals and health related magazines, research and regulatory documents, information brochures for patient education, etc.
The medical writers must be able to present the scientific data as per the need of the respective audience, i.e. as highly technical writing for a scientist or as a simple and lucid consumer educational writing for the general public. The first step in medical writing is literature search and review of information, it is essential that the information must be from reliable sources. The next step is to mould the available information as per the understanding of the audience. The contents must be well-organized, effectively illustrated, and well-correlated so that a constant flow of information is maintained through the document.
Drafting of an unambiguous, clear and precise set of information is the basic requisition. After the drafting has been completed the document undergoes several review processes to make it more effective, concise and well communicative.
Medical writing can be categorized as regulatory medical writing and educational medical writing. The Regulatory writing involves drug approval documents for New Drug Approval(NDA), Abbreviated New Drug Application (ANDA), Protocols for Clinical trials, Standard Operating Procedures (SOPs) Investigational Brochures, Clinical Study Reports, Patient Consent Forms, Periodic Safety Update Reports (PSUR), Annual Safety Reports (ASRs), as well as other documents that are collected in the course of drug development process. The Educational writing involves the documents that are meant for the medical professionals (E.g. Prescribing Information, medical journal articles/ manuscripts (research articles, review articles, case reports) posters and presentations for medical conferences, promotional literature of newly launched medicinal products) or for the patients and general public (E.g. Patient information leaflets, patient education material, etc.).
Medical writing has been established as an integral part of the pharmaceutical industry. With the increasing demand of medical writers, the pharmaceutical companies and other health care organizations are also looking for Key opinion leaders, who are creative and have expertise in the development of new therapies as they have thorough understanding of medical science. KOLs work with medical writers to provide important information on disease condition and patient regimen to help the pharma industries in exploring, launching and promoting new pharmaceuticals and medical devices. As a result, medical writers together with KOLs contribute to the growth of the industry.
We at WorkSure™ offer full range of medical writing services for scientific communications, medical education, patient and public education, medico-marketing materials and regulatory submissions across diverse therapeutic areas for all phases of products from Phase I to post market and beyond. With well written, well documented and on time communications, the mission of WorkSure is to contribute to the success of providing optimum healthcare.
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