De-Risking Early Clinical Development

Elizabeth Allen, PhD, Raymond Cook and Janet Rosasco from IQVIA's Early Phase Center of Excellence explore how biotechs can navigate uncertainty in early clinical development, including adaptive trial designs and AI-powered insights.

Adaptive and Hybrid Trial Designs

Flexible designs allow real-time dose adjustments based on emerging safety and efficacy data, reducing patient numbers while improving the likelihood of identifying the optimal Phase II dose.

Seamless Phase I to Phase II Transitions

Pre-specified adaptation rules let sponsors move from dose selection directly to proof-of-concept without the delays of separate study start-up.

Regulatory Strategy

Early-phase data expectations differ across FDA, EMA and PMDA. A global regulatory strategy built early helps sponsors avoid costly rework and supports efficient worldwide development.

AI-Powered Insights

Machine learning supports patient selection, site identification, safety monitoring and dose optimization, accelerating proof-of-concept while preserving capital and investor confidence.