Full Service Medical Writing

Our medical writing team has extensive industry knowledge and therapeutic expertise to effectively meet client product development requirements.

Our medical writing services include:

  • Protocol development
  • Investigator brochures
  • Informed consents
  • Pediatric Assents
  • Clinical Study Reports (Phase I, II, III, and IV)
  • Clinical Plans
  • Safety narratives
  • Pediatric Investigation Plans
  • Data and Safety Monitoring Board (DSMB) charters and reports
  • Interim data summaries
  • Scientific Advice Briefing Documents
  • NDAs/BLAs/MAAs
  • Abstracts and manuscripts
  • Integrated Summaries of Safety (ISSs)
  • Integrated Summaries of Efficacy (ISEs)

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