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. As a result of our medical writers’ experience, the accuracy of the reports is enhanced, and final report editing is reduced.

GRS’ Quality Assurance Department reviews the clinical study report and reconciles it with study outputs. A final draft of the clinical study report is not considered complete until QA has signed off on the review. All findings from the QA review and all client comments and edits are resolved prior to release of the final draft of the report.