Published in pharmaphorum, January 2025

The article discusses the complexities and challenges of transitioning active clinical trials to comply with the EU Clinical Trial Regulation (CTR) 536/2014. It highlights the need for clinical trial sponsors to meet new process requirements and timelines to ensure their EU-based programs stay on track. Authors Chris Bamford, Director of Clinical Trial Regulatory Management at IQVIA and Shirley Rutter, Associate Director and Strategic Quality Lead of Global Quality Management at IQVIA Biotech addresses key questions and considerations for successfully transitioning trials, such as the amount of information needed, application processes, project timelines and potential impacts on trial subjects. Click to download the full article.

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