Summary
This document is a commentary discussing the evolution of clinical trials, particularly focusing on mixed Functional Service Provider (FSP) and Full-Service Outsourcing (FSO) models. It outlines the challenges sponsors face due to increasing complexity and costs in drug development, including the rising expenses of clinical trials. The commentary explains how sponsors have traditionally relied on FSO and FSP models and are now increasingly adopting mixed models to enhance flexibility, speed, and control. It details how these mixed models allow for efficient scaling of teams and integration of specialized expertise, especially in areas like pharmacovigilance and safety monitoring. Furthermore, it describes the benefits of utilizing regional expertise and remote-based resources to improve operational efficiency in clinical trials, particularly in navigating local regulations and enhancing patient recruitment. The commentary emphasizes that mixed FSP/FSO models are becoming essential for optimizing clinical development operations and ensuring timely delivery of new treatments.
