Streamlines Regulatory Compliance

The Core Principle

Regulators are increasingly focused on the quality and efficiency of clinical trials. A well-documented feasibility analysis demonstrates due diligence and a proactive approach to risk management.

Why It's Critical

It helps in anticipating regulatory questions and ensuring the trial design is compliant with local and international standards from the outset, which can lead to a smoother and faster review process.

Real-World Impact

During a regulatory review, an agency questions the proposed enrollment timeline. The sponsor provides their detailed feasibility report, which includes site-level enrollment projections and historical data. The agency accepts the justification, avoiding a clinical hold and months of delay.