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EU CTR: Final Countdown, What You Need to Know

The end of the transition period is imminent. How can clinical trial sponsors and CROs ease the transition to CTIS?

Soon, the one-year transition period of the EU’s Clinical Trials Regulation (CTR) will come to a close. EU CTR aims to harmonise the clinical application process across Europe and increase transparency. The regulation envisions a faster and more streamlined submission and approval process for larger multinational studies. Soon, biopharma sponsors, contract research organisations (CROs), the European Medicines Agency (EMA), and member states will use one system to manage all trial applications and authorisations.

Sponsors and CROs have spent the transition period learning how to navigate the Clinical Trials Information System (CTIS) for their study registration and approval activities, which will be a mandatory requirement from 31st January 2023. Having a common regulatory approach across the European Union will boost regional competitiveness. Patients are set to benefit from improved transparency of trial data, as data submitted within applications will be made public, making it easier for patients to identify and participate in ongoing trials.

To date, almost 100 studies have already been submitted under the new regulation, with Veeva customers accounting for at least half of these. The initial feedback from sponsors and CROs alike is that it is challenging to remain efficient while complying with legal responsibilities. Companies have had to improve communication, collaboration, and alignment across diverse global study stakeholders and departments.

Rethinking Our Approach to People, Processes, and Data

In its present format, the backbone technology of CTIS is not easy to integrate. Sponsors and CROs are collating data in their own technology environments. Each document in a study submission needs to be individually isolated and manually uploaded to the CTIS portal. Process timelines are getting longer, as companies spend more time collecting data points and information while managing translations and redactions. Once the submission has been made, companies often find they have a small window to respond to questions and requests for further information from the EMA.

How should companies address these challenges? Those that have successfully navigated the new process first had to attain internal alignment. This meant acknowledging that the old way of interacting with regulatory authorities was no longer sufficient and mapping out which internal stakeholders should be brought into the process, and when. Some created new roles to reflect the new reality, including managing translations or uploads to the portal. Others have redefined the RACI framework for clinical and regulatory study leads to maximise efficiency. All agree that technology plays a crucial role in improving collaboration across diverse stakeholders by making it easier to search for and extract data quickly, as well as draw on internal expertise during submission.