Medical Writing

Clinipace Worldwide medical writers produce documents for all stages of clinical development including literature summaries, pre-FDA meeting briefings, regulatory filings, protocol development, Common Technical Documents (CTDs), case report forms, clinical study reports, investigator brochures and annual updates, informed consent forms, and IRB communications, DSMB reports, and scientific abstracts, manuscripts, and journal articles.

Our Medical/Technical Writing services include:

  • Investigator Brochures
  • Development of clinical operating plans
  • Study Design
  • Review of Documents
  • Protocols
  • Informed Consent Forms
  • Case Report Forms
  • Study Manuals
  • Integrated Study Reports
  • Expert Summaries for international regulatory submissions
  • Abstracts and journal articles