R2 Implementation and CRO Oversight Case Study

Our client, a large global biopharmaceutical company had recently merged with another similar company. The QA department of the resulting company was met with the task of both integrating two quality management systems as well as preparing for ICH E6 (R2). To add further complexity to their situation, our client was also looking to streamline the number of strategic CRO partners and wanted to make sure they were selecting partners which were ready to operate under the R2 guidance.