Improving Protocol Design With An Early Think-Tank Initiative

Speeding up development timelines is a critical goal for biopharmaceutical companies, and Parexel advocates for a strategic approach that starts with careful planning and protocol testing early in the process. A longtime client approached Parexel at the perfect time, entering the first-in-human phase for a cancer drug. Despite having preliminary clinical trial plans, the client faced uncertainty regarding the clinical and regulatory feasibility of their strategy. To address this, Parexel proposed a gap analysis and a “think tank” approach. This session brought together Parexel’s multidisciplinary experts, including project leads, medical, regulatory, and feasibility specialists, to examine the client’s plans and identify potential risks. Within two weeks, Parexel provided a detailed analysis, including recommendations and suggestions for overcoming gaps. This led to a Request for Proposal (RFP) for a full feasibility strategy, utilizing Parexel’s advanced tools to assess industry trends and other factors impacting development. The result was a dramatically improved protocol design, focused on effective, patient-centric trials and an efficient regulatory process. Parexel’s collaborative approach helped the client refine their plans, ensuring that trials were conducted correctly, producing the necessary data and fostering strong engagement with the sponsor. Ultimately, this early-stage consultation allowed the client to streamline the entire development process, accelerating their time to market and reducing costs, proving the value of pressure-testing plans from the start.