|
India has become the preferred destination for medical tours. Indian subcontinent has been excelling in various medical studies and researches. Medical writing is becoming a prosperous segment in the medical industry today and the market has expanded by 15 percent. It has reached approximately to $700 million and promises to expand even more in the forthcoming years. For this expansion a lot of credit can be attributed to the percentage of work and medical assignments that have been outsourced from drug sponsors. The work needs to fulfill various regulatory needs and convert conventional information to manuscripts for scientific and medical publications. The demand for medical writing is increasing gradually, with renowned pharmaceutical organizations bringing down job opportunities as a part of the revamping objectives. Furthermore, we have medical writers who are now continuing their work as freelancers than full time medical writers in medical institutes. Hence the outcome is that that ones who are still engaged in medical writing on a contract basis, including full service clinical research organizations (CRO), freelance writers and medical communication firms report a huge demand for these services. However, leading CRO’s in India provide medical writing services as a part of their clinical trial process. How Medical Writing Works Medical writing evaluates and analyzes the studies, protocol, data, statistics and their respective meaning. It also has the ability to interpret the data and write them in a simple and clear format so that it is easy for everyone to understand the same. Hence, medical writers have an essential part to play in narrating the product background. CRO’s in India employ medical writing groups that are adequately experienced and qualified and stick to the requirements of the various regulatory report rules. The teams ensure that every regulatory submission documents are clear, concise, medically and scientifically accurate and is completely compliant with ICH and regulatory guidelines along with submission reports that are set up in CTD and eCTD formats. Any medical writing group is well trained and has the ability to mix together abstracts, manuscripts and publications. Medical Writing service portfolio in popular CRO’s include Protocol, Investigation Brochures, Informed Consent Documents, Case Report Forms, Study Reports, eCTD, Scientific Papers for publication and Med Xview for e filing. Few other Medical Writing services include the following:- Bioanalytical services and reporting 1. Method Validation Reports 2. Bio analytical Reports 3. ISR Reports 4. Submission-ready Documentation 5. Dispatch & Archival Clinical Reporting 1. Clinical Study Reports 2. Integrated Safety & Efficacy Reports 3. Pharmacovigilance & Safety Reports 4. Presentations, Posters & Manuscripts Well known CRO’s today take interest in demonstrating their experience and wants to cater to the international regulatory reporting requirements for Medical Writing. This is specified by multiple agencies and sponsors. Read Also On: Phase 1 Studies, Clinical Pharmacokinetic
Related Articles -
clinical research organizations, Medical writing, Phase I Studies, Clinical Pharmacokinetic,
| 
