medical writing

From protocol development to clinical study reports and regulatory documents, ClinDatrix medical writers, reporting to Dr. Ned Whittemore, ensure clear written communications with sites, investigators and regulatory agencies throughout the product development and commercialization process.

Among the types of documents our medical writers prepare are the following:

Clinical Documents

  • Clinical protocol, protocol synopsis and protocol amendments
  • Investigator brochures
  • Interim clinical study reports (CSRs)
  • Final CSRs

Medical Monitoring and Patient Safety Documents

  • SAE reports with narratives
  • Annual safety reports

Regulatory Documents

  • INDs, NDAs
  • PMAs, IDEs, 510(k)s
  • Annual reports (IND, NDA, orphan drug, etc.)
  • Periodic safety update reports
  • Module 2 and Module 5 summaries
  • Non-clinical study reports
  • Agency cover letters and communications
  • Briefing documents
  • Agency response documents
  • Product labeling
  • Requests for meetings

Journal Articles

Technical Analyses