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