22 Sep How Europe’s rules for clinical trials are changing

The new European clinical trial regulations are a great opportunity for CROs and companies involved in clinical research. Our medical translation agency wants to share with you how the new Clinical Trials Information System will help centralise processes and streamline studies.

Excellence in clinical trials

One of the main objectives of the European regulations on clinical trials is achieving excellence in this type of work. Indeed, this can be the foundation for a strong biomedical research ecosystem, which will also boost basic and pre-clinical research and help European countries become leaders in medical research.

Specifically, the new Clinical Trials Information System harmonises the processes for the submission, assessment and monitoring of clinical trials. The aim? To speed up these studies and, as a result, to get new, effective and safe medicines more quickly to the people who need them.

Thanks to this procedure, clinical trial sponsors will now be able to apply for authorisation for a trial simultaneously in all EU countries. They will have to do this through a single application that results in submissions to the competent national authorities, ethics committees and public registration of the clinical trial.

Use of a centralised platform

The European Medicines Agency (EMA) has requested that clinical trial applications be submitted through this system now. However, there is a timeframe to adapt to the new system. As of 31 January 2023, clinical research companies will have to use the new central platform. All study information will have to be fully transferred to this system by 2025.

Clinical trials not only offer new hope for patients, but also have very positive financial consequences for the healthcare system. They attract funding from the sponsoring pharmaceutical companies which goes to the participating hospitals, both public and private, and they are the leading source of private income for these centres. In addition, they improve the reputation, experience and knowledge of the healthcare professionals involved in running them, placing them at the cutting edge of science, which they can then apply in their healthcare work. If in addition we consider the process of medical translation to disseminate research advances, the result is spectacular.