Lessons Learned as Early Adapters of the EU’s Clinical Trials Regulation

By Marita Kruskopf Osterberg, PhD and Bernarde Bau, BSc, MSc

The European Union’s Clinical Trials Regulation (CTR) has harmonised the process for authorisation and   supervision of clinical trials in EU and the European Economic Area (EEA). Originally deployed on 31st of January 2022, the new process makes it possible to submit one online application to gain regulatory and ethics committee approval to run a clinical trial in several European countries.

As early adapters of the Clinical Trials Information System (CTIS), our first submission occurred in May 2022 and many have followed, allowing the Allucent team to gain valuable practical experience and understanding of the new process. Below, our experts compiled some of the lessons learned.

Training and knowledge are necessary

As CTR works to harmonize the process and requirements of many countries into one place, a more centralized outlook is required when submitting your applications. The Allucent team has therefore restructured itself to be more aligned with the new system, including the creation of an EU CTR expert role.

Increased transparency is a major factor

Our early experiences with CTR and the CTIS portal allowed us to note significant changes to information transparency. The public portal is an open-source platform available to everyone, providing searchable, detailed information on clinical trials.  

Such a public audience necessitates a new approach to adequately protect confidential information. We recommend educating yourself on this matter early on. Thereafter, conduct internal discussions on what commercially confidential information you would like to protect long before the decisions need to be made, so that these discussions will not be rushed.  We at Allucent can guide you in this process and ensure that appropriately redacted documents are ready in time for submission. We have created the new role of submission document redactor with sole responsibility to redact personal and commercially confidential information from submission documents.

Timelines are more strict

While timelines may have had some flexibility in the past, they are much stricter under the new regulations. Sponsors now only have 12 calendar days to respond to queries from the authorities. If you miss the deadline, the full submission lapses and you must begin again.  Allucent has gained indispensable experience in how to prepare for and manage these extremely tight time frames, which we are happy to share with our sponsors.

The system continues to evolve

The CTIS was set up to improve communications and processes when it comes to trials in the EEA. No system is perfect in its creation, but the CTIS has continued to make changes and evolve over time. Many issues that cropped up in the early stages have been eliminated and there are ways to work around those that still exist to ensure you meet your timeline objectives.

Experience is incredibly valuable when it comes to navigating bugs in CTIS and keeping an eye on new developments. At Allucent, our team has been working in the new portal since the beginning and have adapted to optimize the new process.

Our services are flexible and can be adjusted to match your needs. We can complete submission for all countries/parts in the portal, including handling accesses and completing parts of the submission. If you prefer to handle the submissions yourselves but would like to tap into our experience, we can offer support and advice for getting you started in the best way.  

Allucent brings new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients. For more details about how the A-Team can support your drug development programs, visit us today

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