Master Protocols & IRT: 5 Questions Sponsors Must Ask Before Selecting A Randomization Partner

By Jennifer Ross, Director - Biostatistics Almac Clinical Technologies

Master protocols introduce significant randomization and operational complexity, making the selection of the right IRT partner critical to long-term trial success. This white paper explores the key questions sponsors should ask when evaluating randomization providers for adaptive platform, basket, and umbrella trials. It examines how experienced IRT partners can support evolving treatment arms, adaptive allocation ratios, protocol amendments, and complex eligibility requirements while maintaining regulatory readiness and operational continuity. Readers will gain insight into the importance of flexible randomization methodologies, purpose-built IRT technology, biostatistical expertise, and long-term partnership models that help sponsors reduce trial disruption, streamline adaptations, and support scalable execution across complex master protocol programs.