Success from Day One
As clinical trials grow increasingly complex, the first 120 days can define a program's success — particularly for emerging biotechs entering the clinic for the first time. A strong start requires a contract research organization (CRO) that moves quickly from proposal to execution, aligning scientific goals, operational strategy, and regulatory readiness from the outset. At the PPD clinical research business of Thermo Fisher Scientific, structured early engagement, transparent communication, and a biotech-focused mindset ensure that every study begins with the right foundation. By establishing clear governance, proactive regulatory mapping, disciplined resource allocation, and open communication channels, emerging biotechs can navigate the high-pressure early phase of a clinical program with confidence and precision.
In this guide, you'll explore
- The first 120 days of a clinical trial are critical: establishing governance, communication structures, and a shared definition of success during this window sets the trajectory for the entire program.
- Proactive regulatory engagement — ideally beginning during the preclinical phase — reduces the risk of costly redesigns and improves the likelihood of first-submission approval for IND applications.
- A comprehensive feasibility assessment and country data packs enable a data-driven site selection strategy that balances patient population access, regulatory timelines, and investigator experience.
- Formal risk-mitigation planning conducted within the first days of project initiation ensures that potential issues are identified early and managed through living mitigation plans that evolve with the study.
- Open, consistent communication between the CRO and sponsor — starting at the proposal stage — builds the trust and transparency needed to maintain momentum even when study conditions shift unexpectedly.