Protocol design is one of the most important drivers of clinical trial success, influencing everything from study start-up timelines and participant recruitment to site burden, protocol amendments, and overall trial efficiency. As trials become increasingly complex, sponsors and CROs face growing pressure to design protocols that are scientifically rigorous while remaining operationally feasible and participant-centered. This whitepaper explores the key protocol design challenges that can hinder trial delivery and highlights practical strategies to reduce complexity, improve study execution, and accelerate clinical development.
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