THinc . . .  a REGULATORY AND MEDICAL WRITING DEPARTMENT

For clients who need to prepare regulatory, clinical, and scientific documents, we can help you develop and write documents with consistent key messages from concept through completion.

Clinical Documents

THinc medical writers have a thorough understanding of the clinical research setting. As a result, we prepare documents that address the needs of various audiences, including investigators and IRBs, medical monitors, project statisticians, study coordinators, and regulatory reviewers. Our experience includes

  • Clinical study protocols and amendments, Phase 1 through Phase 4
  • Clinical study reports, Phase 1 through Phase 4, based on ICH guidelines, including
    the core report and all appendices (i.e., Sections 1 through 16 as defined in the
    E3 guideline)
  • Investigator’s brochures, from first-in-human brochures to late-stage
    drug-development brochures
  • Patient safety narratives
  • Interim data summaries
  • Data and safety monitoring board reports
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