Amid growing uncertainty in the U.S. regulatory landscape, sponsors are increasingly looking to ex-U.S. markets as a strategic way to reduce clinical trial risk and maintain momentum. In this episode, Novotech experts Renita Hite and Scott Schliebner discuss how biotech and small to mid-sized pharma companies are adapting their global trial strategies—leveraging regions like APAC and Eastern Europe for faster startups, strong data quality, and significant cost savings. They explore:

-Why sponsors are increasingly looking outside the U.S. amid regulatory and political uncertainty

-Key benefits of ex-U.S. regions like APAC and Eastern Europe, including speed, quality, and cost savings

-Strategic considerations for integrating global sites into clinical development plans

-Common pitfalls and risk mitigation strategies when operating in international markets

-How ex-U.S. trials support greater flexibility and resilience heading into 2025–2026

This episode is part 3 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials.

Listen to part 1 here: Podcast Series: Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials

Listen to part 2 here: Podcast Series: Navigating Regulatory & Market Shifts — CRO Perspectives on Clinical Trials