Delivering Complex Oncology Trials At Scale

Delivering large, late‑stage precision oncology trials requires rigorous planning to overcome unique operational, regulatory, and logistical challenges. This case study describes how Parexel successfully executed two concurrent, multinational Phase III prostate cancer trials evaluating a radiopharmaceutical imaging agent with an ultra‑short shelf life.

Conducted across the United States and Europe, the studies required synchronized manufacturing, shipment, and same‑day imaging, while coordinating multiple medical specialties and managing high volumes of complex imaging data. Parexel implemented a targeted site selection strategy emphasizing proximity to manufacturing hubs and proven cross‑disciplinary collaboration, supported by proactive vendor engagement and detailed regulatory planning for radioactive material handling.

These approaches enabled timely investigational product administration, efficient imaging workflows, and accelerated enrollment—exceeding industry benchmarks and achieving critical milestones ahead of schedule. The outcome highlights how strategic site selection, operational precision, and regulatory expertise can enable scalable, high‑quality execution of complex prostate cancer trials, supporting sponsor timelines and regulatory submission goals.