Enhancing Clinical Trial Flexibility

By Craig McIlloney, MSC, BSc Hons, Senior Vice President, Catalyst Flex and Svetlana Kolchinsky, Vice President, Catalyst Flex

As drug development costs climb, sponsors increasingly turn to functional service provider (FSP) models as an alternative to traditional full-service outsourcing. Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise across clinical operations, data management, biostatistics, medical writing, and safety. This adaptability enables biopharmaceutical and biotechnology companies—particularly smaller firms underserved by large CRO models—to optimize resources, control costs, and accelerate timelines without sacrificing quality.

FSP models thrive on customization, offering solutions that range from providing individual experts to deploying fully integrated teams across multiple programs. The approach allows sponsors to retain oversight while benefiting from specialized knowledge and infrastructure integration. By fostering collaboration, responsiveness, and scalability, FSP partnerships reduce inefficiencies such as turnover and resource misalignment, common in traditional outsourcing. As clinical trials grow in complexity, Functional Service Providers are positioned as vital enablers of cost-effective, adaptive development strategies that ensure both operational agility and scientific rigor.