Medical Writing

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

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