Document QC

Our meticulous QC specialists will identify even the smallest of content and format errors/inconsistencies, as well as regulatory compliance issues in critical health authority documents prepared by our clients or their contractors. These documents include:
Clinical Study Protocols, Clinical Study Reports, CTD Module Summaries, Patient narratives, Risk Management Plans, Summary of Product Characteristics, Periodic Safety Update Reports, Annual Safety Reports, Investigator Brochures, and Manuscripts.

Detailed QC findings reports include a comprehensive explanation of findings, recommended corrections and revisions.