The EU CTR has established a harmonised approach for clinical trial applications, assessment and reporting with consistent rules. The ultimate aim is to ensure the highest safety standards for clinical trial participants by strengthening transparency and consistency. A key feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions.
Following its implementation in January 2022 there has been a phased transition period for new and ongoing clinical trials. As of 31st January 2023, all new European Union or European Economic Area Member State submissions must be made via the EU CTR process.
In this white paper, ICON’s experts offer strategic considerations for sponsors in addition to providing insights on the following:
Download this whitepaper to learn more about how the EU CTR can impact your trial.