Episode description:
In 2025, geopolitical tensions, regulatory shifts, and new FDA directions reshaped the clinical development landscape. In this four-part podcast series, Novotech experts break down what these changes mean for sponsors planning early-phase and global trials.
The series examines evolving expectations from the FDA, EMA, and TGA, how sponsors are adjusting trial locations and development strategies, and practical steps to manage cost, timelines, and regulatory uncertainty. Across all episodes, you’ll gain clear, actionable guidance on site selection, risk planning, and adapting programs to a rapidly changing clinical environment