Expanding Clinical Trials Internationally In The ATMP Space

Improving clinical trials beyond international borders is a critical step for advanced therapy medicinal product (ATMP) developers aiming to reach wider patient populations, accelerate development timelines, and generate more robust clinical data. Yet, taking ATMP trials across borders presents a unique set of challenges—from navigating diverse regulatory landscapes and ensuring cold chain continuity, to coordinating logistics, site readiness, and patient safety across multiple countries. Unlike traditional therapies, ATMPs often involve complex, patient-specific manufacturing processes and ultra-sensitive materials that require precise handling and real-time visibility throughout the supply chain. Still, with careful planning and the proper infrastructure, international expansion can become a strategic advantage rather than a barrier to progress.

Explore key considerations for successfully increasing global trials in the ATMP space, including regulatory strategy, site selection, customs and trade compliance, and the importance of integrated logistics partnerships while gaining insight into how early planning, scalable infrastructure, and the right partners can lower risk, reduce delays, and support international execution.