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Understanding CTIS Guidelines and Process Implications

Aligning your organization to the new clinical trial systems landscape in Europe


In order to streamline clinical trial submission and management, the CTR leverages a new online portal and database called the Clinical Trial Information System (CTIS). CTIS went live on January 31st, 2022 and serves as the single entry point for clinical trials information. CTIS is intended to considerably simplify the clinical trial application process, however organizations initiating new applications or transitioning ongoing trials will face some challenges implementing the new system. This paper will provide an overview of CTIS as well as outline key challenges and considerations for sponsors in preparation for the upcoming mandatory implementation of CTIS.

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