Navigating the Landscape of Clinical Trial Applications under the EU Clinical Trials Regulation: Insights and Challenges

Ahead of the 31^st of January 2024 marking a year until all EU clinical trials need to be compliant with the EU Clinical Trials Regulation (CTR), this whitepaper delves into different aspects we have observed that can become ‘sticking points’ for Sponsors wanting to conduct clinical trials under the CTR. Our analysis has highlighted six key topics, encompassing our experience of the overall clinical trial application (CTA) assessment process, data transparency and publication, transitioning from the Clinical Trial Directive (CTD) to the CTR, the EU CTR Systems Environment, EU Legal Representative requirements, and Article 32 paediatric requirements.