Medical Writing

Medical writing is an integral part of clinical research. The Medical Writing Unit at TFS is fully qualified and experienced in the production of Clinical Study Protocols and Study Reports according to ICH GCP guidelines as well as a wide range of medical and scientific documentation required to support product development efforts.

TFS Medical writers are able to provide global trial support as well as specific regional/country requirements including Asia Pacific. The documentation provided by our medical writers is clearly written and compliant with all ICH guidelines and regulatory requirements, and they can be written in most European and some non-European languages.

The Medical Writing Unit also prepares documents for Medical device products.

All regulatory documents are formatted and prepared for electronic submissions.

Our services include:

Clinical Studies/Investigations

  • Design
  • Protocols
  • Reports
  • IMPDs/INDs/Investigator’s Brochures
     

Scientific Production

  • Bibliographic Reviews
  • Publications
  • Abstracts
  • Posters
     

Regulatory Documents

  • Preparation of documents for submission (remediation/publishing)
  • Clinical Summaries/Overviews
  • Briefing/Response Documents

 

TFS has Medical Writing teams based in the US and Europe.