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Streamlining early phase clinical trial submissions under the EU CTR

The EU Clinical Trials Regulation (CTR) represented a significant shift in the regulatory landscape, aiming to create a more favourable environment for clinical research across Europe. ICON has adeptly adapted to these new regulations, leveraging our Netherlands efficiencies model to streamline submissions and ensure rapid turnaround times.

ICON’s current experience to date includes 47 submissions, with 40 approved. The one-round request for information (RFI) average stands at 40.2 days, with a minimum of 35 days and a maximum of 46 days. This demonstrates ICON’s ability to efficiently navigate the submission process, minimising delays, and maximising approval timelines.

EU clinical trial submission workflow

Understanding the EU CTR

The EU CTR replaces the previous Directive 2001/20/EC, introducing several key changes to the clinical trial submission process. These include a single submission portal and a coordinated assessment procedure, designed to streamline the process, reduce duplication, and enhance the quality of clinical trials conducted across Europe. While these changes bring numerous benefits, they also require sponsors to adjust to new procedures and timelines.

To ensure a swift and efficient submission process under the EU CTR, ICON has implemented several key strategies. Immediate responsiveness is achieved by notifying the Institutional Ethics Committee (IEC) via email, ensuring preapproval of advertising materials sent in advance. The validation process features a quick turnaround, with rapid follow-up upon receiving responses to expedite validation. IEC meetings are scheduled timely to facilitate quick site activation post-award, with advertising conducted prior to package approval. Prompt responses to requests for information (RFIs) are crucial for maintaining the momentum of the submission process. Upon receipt of the letter of approval, the greenlight procedure can be performed, allowing screening to commence immediately after the site initiation visit.

Lessons learned - early phase

Based on our extensive experience, ICON has identified several key areas to focus on to ensure a smooth submission process and maximise approval timelines. Early determination of requirements and roles for OMS registration, along with reviewing expectations and requirements in advance, is critical. Applying for the EU CT number early in the study start-up phase helps avoid delays.

XEVMPD registration of the investigational medicinal product (IMP) is necessary for both the drug substance and product for IMPD submission. Deciding whether a single country or single site approach is most appropriate and choosing the Reporting Member State (RMS) and local IEC accordingly is essential. Prioritising study team activities ensures a fast turnaround of responses and document updates. 

Additionally, maintaining open communication and meeting planned timelines through effective collaboration and clear expectations are vital. Regularly consulting EMA guidance documents and asking questions helps stay informed and prepared. Conducting a thorough review of the scope and resourcing of services ensures alignment with project goals and helps avoid changes.

ICON's commitment to excellence

ICON’s strategic approach and dedicated processes ensure that we can leverage the opportunities presented by the EU CTR while adhering to our legal responsibilities. By focusing on efficient communication, thorough planning, and prompt responses, we are able to streamline the submission process and achieve fast turnaround times. This commitment to excellence not only benefits our clients but also contributes to the advancement of clinical research in Europe.

In conclusion, ICON’s experience and strategic approach to the EU CTR submission process highlights our ability to navigate regulatory changes effectively. By implementing efficient procedures and maintaining open communication, we ensure that submissions are timely and meet the high standards required by regulatory authorities. Our track record of successful submissions and quick turnaround times demonstrates our capability to support sponsors in achieving their clinical research goals under the new regulatory framework.

 

If you would like to discover how ICON can assist you with your early phase clinical trials, then please visit ICONplc.com/earlyphase

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