This IQVIA insights guide presents a framework for reducing unnecessary regulatory burden while maintaining patient safety and scientific rigor in drug development. The paper advocates for “right studies at the right time” by using phase-appropriate, risk-based evidence strategies that eliminate redundant testing and accelerate clinical entry. Leveraging prior knowledge, modeling and simulation, adaptive study designs, and targeted regulatory engagement, sponsors can streamline development programs while reducing costs. IQVIA outlines practical approaches for optimizing preclinical studies, clinical trials, chemistry and manufacturing activities, and global regulatory strategies, helping organizations reach first-in-human studies and key development milestones more efficiently.

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