Medical Writing Service Portfolio Of Indian Cro’s

By Author: Alice Coope
Total Articles: 213
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In today’s day when there are vast opportunities for every profession, Medical Writers are successful in finding their ways to various kinds of organization. As full time professionals, medical writers are absorbed in by biotechnology and pharmaceutical companies, health regulatory concerns, clinical research organizations (CRO’s), communication agencies as well as other healthcare journals.

In the recent past, there have been medical writers working on pharmaceutics and biotechnology firms, and contract research agencies. They are engaged in regulatory medical writing and also contribute towards the preparation of various kinds of medical documents that are required for submissions to international regulatory agencies, for instance US FDA, EMEA, DCGI and many more. These agencies are involved in clinical studies and clinical research. Many of these documents happen to be clinical study report, clinical study protocol, informed consumer forms and the like. Furthermore, medical writers also help in writing manuscripts for publishing multiple national and international scientific ...
... and medical journals. Generally, a pharmaceutical company with a huge portfolio of drugs in the market has medical writing assignments that deal in setting up medico-marketing materials, website content, training manuals and other regulatory documents.

In the recent past, there have been numerous clinical research organizations (CRO) in India that have specialized in offering medical services in India. They house a qualified team that is experienced to comply with the needs of different regulatory report guideline. The medical writing team makes sure that every regulatory submission documents are concise, clear and scientifically and medically accurate and completely compliant with all the applicable ICH and regulatory guidelines with submission reports offered in eCTD and CTD formats. Furthermore, the writers also have the expertise in compilation of tasks such as manuscripts, abstracts and other publications. The medical writing service portfolio includes protocol, informed consent documents, investigation brochures, study reports, scientific papers, case report forms, eCTD for publication and Med Xview for e filing. There is a separate report compilations and dispatch team. Other services offered comprise of the following:-

Bioanalytical reporting

* Method Validation Reports

* Bio analytical Reports

* ISR Reports

* Submission-ready Documentation (Hyperlinked eCTD formatting)

* Dispatch & Archival

Clinical Reporting

* Clinical Study Reports

* Integrated Safety & Efficacy Reports

* Pharmacovigilance & Safety Reports

* Presentations, Posters & Manuscripts

In the recent past, popular Clinical Research Organizations in India has demonstrated their experience in catering to international regulatory reporting needs for Medical Writing as spelled out by numerous sponsors and agencies. Quick turn around time is guaranteed for every final report.

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