Services

Medical Writing

The GRS medical writers have extensive experience producing clinical study reports complying with ICH E3 (Structure and Content of Clinical Study Reports) guidelines, as well as with reporting of results from drug and device trials. In addition, we work with your team to prepare the clinical summary sections of a regulatory submission, or provide a complement of experienced writers with extensive experience writing integrated summaries of efficacy and safety data in New Drug Application (NDA) and Common Technical Document (CTD) formats.

GRS professional medical writing effectively organizes, edits and presents scientific information in a comprehensive, concise manner. We combine our experience in therapeutic areas with our experience in creating study documents that adhere to all ICH and regulatory guidelines and good clinical practices (GCPs). We produce well thought out documents for any stage of a study design, including protocols, protocol synopsis, Informed Consent Form (ICF), Investigator Brochure (IBs), newsletters, Clinical Study Report (CSR), FDA briefing packages and all regulatory document submissions to the FDA and international governmental regulatory agencies with translations into appropriate regional languages. As a result of our experience, the accuracy of documents generated is enhanced, and final report editing is reduced to bring you more value for our services.