Success from day one: How emerging biotechs can maximize the first 120 days of their clinical trial

As clinical trials grow more complex, the early months of a study have an outsized impact on long-term success. This is especially true for emerging biotechs entering the clinic for the first time, where scientific goals, operational planning, and regulatory considerations must align quickly and effectively. The increasing sophistication of drug platforms, rising protocol complexity, and the challenges faced by sites—many managing multiple studies with limited resources—create additional pressures on early trial execution. Understanding how to structure those first 120 days enables sponsors to anticipate obstacles, strengthen collaboration, and build a stronger foundation for the work ahead. Clear communication, thoughtful planning, and a well-coordinated approach to study start-up are key elements that meaningfully influence timelines and study quality.