Medical Writing

Clear, compliant medical writing and documentation tailored to support oncology trial success.

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ICH GCP & CFR Standards

Compliance-Focused Medical Writing Team

Medical writers collaborate with medical monitors, scientific experts and sponsors on all writing projects to follow the requirements of ICH GCP and the US Code of Federal Regulations (CFR).

  • Clinical Study Protocols and Amendments
  • FDA Briefing Documents
  • Clinical Study Reports (CSRs)
  • Investigator Brochures (IBs)
  • Patient Informed Consent Forms (PICFs)
  • Executive Summaries for Efficacy or Safety
  • New Drug Applications (NDAs)
  • Orphan Drug Applications
  • Investigational New Drug (INDs)
  • IND Annual Reports/ DSURs
  • Patient Narratives
  • Package Inserts
  • Abstracts, Posters and Journal Articles