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EMA certifies Sermes CRO as a key entity in the CTIS Training plan
Sermes CRO has been elected by the EMA as “Train of trainers” for the new Clinical Trial portal, CTIS (Information System). “This election by the EMA means a new step forward for Sermes CRO, which will allow us to continue contributing to the development of the pharmaceutical industry and the harmonization of regulations among member countries of the European Union” explains Lidya Domínguez, Clinical Trial Start Up Unit Manager at Sermes CRO.
Sermes CRO has been elected by the EMA as “Train of trainers” for the new Clinical Trial portal, CTIS (Information System). “This election by the EMA means a new step forward for Sermes CRO, which will allow us to continue contributing to the development of the pharmaceutical industry and the harmonization of regulations among member countries of the European Union” explains Lidya Domínguez, Clinical Trial Start Up Unit Manager at Sermes CRO.
As a member of the group of experts who advise the European Medicine Agency in the creation and implementation of CTIS (Clinical Trial Information System), Sermes CRO has been involved in this ambitious and necessary project since 2017. Our Clinical Trial Start Up Unit, through its top manager, Lidya Domínguez, has been an active part of the Working Group in charge of testing and modelling this new tool, which will harmonize the processes of assessment and monitoring of clinical trials throughout the EU. “Now the challenge is to transfer all that knowledge to other players in the industry,” ensures Lidya Domínguez.
Within this framework, the EMA has launched the mentioned Train of trainers program in which only 100 European entities have been selected, Sermes CRO between them. These organizations will be the first ones to receive EMA’s certification as CTIS Train of trainers.
EMA’s new portal for clinical trials, CTIS, will be available in January 2022. The complexity of the new system whose proper functioning shall be ensured before its launching has caused several delays throughout the project that has also been developed during the Covid-19 pandemic in its last stage.
However, everything points to the fact that the delay announced by the EMA (that has postponed CTIS’ launch date from December 2021 to January 2022) will be the last one. This means that the times of the pharmaceutical industry and all players involved in clinical research to implement the use of this new tool will start counting from the beginning of next year.
We must be particularly focused on its implementation in all organizations within the industry, especially in the case of sponsors and CROs, whose submission activity will be directly affected by the implementation of CTIS. Likewise, other important entities in the clinical research scenario, such as the much-needed academic research, will also have an important challenge to implement this new system in their day-to-day work.
“At Sermes CRO we have been preparing this change in our organization since 2017, to ensure the quality of our services in 2022, the date of launch of CTIS. We are ready to undertake the great change and help our clients to have a safe transition, meeting high quality standards” insists Domínguez.
From the time of the launch of CTIS, scheduled for January 2022, there will be a three-year adaptation period. CTIS will contain the EU centralized portal and database for clinical trials foreseen by the Regulation (Regulation (EU) n ° 536/2014). The European Medicines Agency (EMA) will set up and maintain CTIS, in collaboration with the Member States and the European Commission.
