Summary
This case study outlines the strategic implementation of a hybrid delivery model for two simultaneous Phase III breast cancer trials conducted by a global pharmaceutical sponsor. The trials, which span over 45 countries and involve more than 10,000 study participants, are supported by Fortrea, which retains operational leadership while collaborating with Academic Research Organizations (AROs) and various vendors. The study details the comprehensive stakeholder engagement process, including the establishment of a governance structure and a communication framework to ensure alignment among all parties. Key aspects of the case study include the management of global vendor relationships, site selection strategies, and patient enrollment approaches. Fortrea's innovative model aims to enhance operational efficiency, reduce competition among studies, and optimize site activation. The results indicate significant advancements in enrollment timelines and sponsor satisfaction, showcasing the effectiveness of the hybrid model in navigating the complexities of oncology trials.
