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Sermes CRO: Updated info about The EMA´s new EU portal of clinical trials (CTIs)

The European Medicines Agency (EMA) aims to have its Clinical Trial Information System (CTIS) ready by December 2021, committing itself to this objective in updating its plans for 2021.

TIS was originally scheduled to be released in September 2018. However, the project has suffered a number of delays since then.

An audit of the system has been carried out, completed in Dec 2020. The tests have revealed significant problems about the quality of the system, which need to be addressed. CTIS is a system with extensive functionality that has been in continuous development for a long period. A year of essential commissioning, a period of stabilization and focus on improving usability, performance and reliability remains ahead. Therefore, development now focuses on improving the quality and stability of the CTIS system, rectifying user test results as well as the results of the first audit field work.

Sermes CRO, as part ogf the group responsible for prioritizing all outstanding issues has made good progress. This group includes representatives of the Member States, the European Commission and the owners of sponsoring products, as well as the EMA.

The version of the platform that EMA will make available in December 2021, may lack some of the features intended for the finished system. EMA aims to deliver a minimum viable product (MVP), a term for a product that has enough features to satisfy early users. Organizations that deliver MVPs collect user feedback for future product development.

The features exactly that are needed for the MVP version of the CTIS remain unclear. The EMA said that the governance of the CTIS program has a responsibility to decide on the minimum set of features needed to make the system available to users.

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