Assessing the Organizational Impact of EMAs Clinical Trial Regulation | Veeva
Summary
The system includes three central areas: • Sponsor workspace – assist sponsors in preparing and compiling data to submit to the system for assessment by Member States • Authority workspace – support the activities of Member States and the European Commission in assessing and overseeing clinical trials • Public website – allow the public to access detailed information on all clinical trials conducted in the EU, in all official EU languages. EMA will make information stored in CTIS publicly available subject to transparency rules. CTR creates a unique opportunity for sponsors to rethink how they manage data and documents. CTR does not mandate a submission in the traditional sense, but rather it requires sponsors to upload clinical documents and data points into CTIS, which in lieu of interfacing capabilities is a manual process. To learn more about how Veeva helps customers adapt to evolving regulations, check out these tips for managing the Brexit transition.