Case Study: Use of OPRA to Identify and Manage High Risk Sites

Our client, a mid sized North American CRO was undertaking a large, global study for a key sponsor customer. The study protocol was complex and required the use of an imaging device which was not common practice for many of the sites. The sponsor also wanted the CRO to take a risk-based approach to on site monitoring, and wanted ongoing quality risk management for the purposes of patient safety, data integrity and ICH E6 (R2) compliance.