Only 6 months left for the transition of all Clinical Trials to CTIS
The deadline for transitioning clinical trials to CTIS ends on January 30, 2025. Studies continuing beyond this date must comply with the Clinical Trials Regulation (CTR), replacing the old CTD. At Sermes CRO, we join the EMA’s effort to communicate this imminent change to clinical trial sponsors in Europe
Assessment and approval of clinical trials in CTIS: Theoretical versus actual timelines
Managing clinical trials on the new European clinical trials platform, CTIS, involves taking into account not only the theoretical timelines foreseen in EU CTR 536/2014, but also the actual time it takes for Member States to assess and approve (if applicable) clinical trials submitted via this route.
We are analyzing the EU CTR and the CTIS at the OCT Europe 2023 congress
Raquel Reviejo, EU Regional Submission Lead at MSD, and Lidya Domínguez, Clinical Research Director at Sermes CRO, will analyze the changes arising from the new European clinical trial platform, CTIS, at the Outsourcing In Clinical Trials Europe 2023 congress. The conference will take place in Barcelona on May 3rd and 4th.
How to register with OMS to be able to work with CTIS?
To be able to carry out a clinical trial in CTIS, it is previously necessary to be registered with OMS. In this article we explain the OMS registration process for sponsors and sites participating in clinical trials
CTIS, year 2023: a critical moment for clinical trial management in Europe
What changes to expect in January of 2023 regarding the management of clinical trials in Europe? What have we learned in this first year with CTR 536/2014 in force and CTIS in operation? How much time is left until the transition period ends? How much time have the sponsors of clinical trials to adapt to the new situation?
Are we making the most of the new European clinical trials platform, CTIS?
We analyze the usage data of the CTIS in its first three months of operation and we present you the new report that the EMA will publish periodically with the main KPIs. It comprehensively monitors the European clinical trial ecosystem.
Conference in Madrid: “CTIS: full application of the European regulation of clinical trials”
The experts participating in our conference agreed to value the CTIS as a tool that will be very useful for the management of clinical trials in Europe, by harmonizing the requirements among different countries and centralizing documentation management
Sermes CRO, first company to manage the submission of a clinical trial in Spain through CTIS
Sermes CRO, together with Mikrobiomik, manages the first submission of a clinical trial in Spain through CTIS (Clinical Trial Information System), the new European clinical trial’s portal.
How to manage transitional clinical trials to the new European online portal, CTIS
The European clinical trial regulation establishes a three-year transition period in order to adapt to the new clinical studies’ online portal. In this article you will learn how to manage the transitions of your studies. It is essential that the sponsors and the CROs actively collaborate with each other in the transition strategy regarding CTIS, according to the different phases over the next three years
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).