Development of a validation framework and validation of Open-Source EDC software for a European physicians’ association

A European contract research organization (CRO), associated with an association of European physicians, needed to validate its Open-Source data collection system (EDC) for conducting clinical trials. QFINITY∞ trained the organization’s employees in the basics concerning GxP, CSV and Part 11, and provided the necessary SOPs and templates for validation and operation, while supporting the ongoing validation of the EDC system (OpenClinica) by coaching.