GCP-Mindset

Welcome to the GCP Mindset Channel, on this channel we inform you about the latest trends and topics in clinical research. The channel contains a mixture of presentations and interviews about several topics which are interesting for persons who work in the clinical research enviroment. The channel has been established by Dr. Andreas Grund, who works since 1997 in the clinical research world at the university and for CROs in different positions. We are happy to share our expertise for a fruitful discourse with you. Do you have a topic in mind that should be adressed in one of our podcasts? If yes, do not hesitate to contact us! The GCP Mindset Channel is powered by GCP-Service International, a 100% privately owned full-service CRO, which conducts clinical studies in several indications globally.

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Interview: Impact of CTIS on TMF Management


The Clinical Trial Information System (CTIS) is a centralized, web-based platform developed by the European Medicines Agency (EMA) to streamline and harmonize clinical trial submissions and regulatory processes in the European Union (EU). The implementation of CTIS is expected to have a significant impact on the Trial Master File (TMF) in clinical research. It will lead to a more comprehensive, accessible, and transparent TMF. But what problems do TMF Manager face in while working with CTIS? Learn more about it in our interview!


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 June 16, 2023  27m