Medical Writing

Intrinsik’s experienced team of medical writers consistently deliver high-quality documents using a flexible operational approach to meet client-specific requirements.

Services:

  • Protocol design and review
  • Investigator’s Brochures
  • Clinical Study Reports (CSR) according to ICH standards
  • Authoring of CTD Module 2.5 and 2.7
  • Integrated Summaries of Efficacy (ISE) and Safety (ISS)
  • Risk Management Plans
  • Product labelling (Product Monograph, Prescribing Information Package Insert, Summary of Product Characteristics, Company Core Date Sheet)
  • Review of statistical analysis plans (SAP)
  • Systematic data review and summarization
  • Abstracts and manuscripts for publication
  • Design, preparation, and review of study documents (study committee charters, adjudication manuals, study operation manuals, scripts, case report forms (CRF), CRF completion manual, etc.)
  • 100% review of documents back to source data to ensure consistency and final quality

 

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

Contact Us