Global Phase III Ovarian Cancer Study Turnaround Case Study

This case study outlines the efforts of Worldwide Clinical Trials to rescue a failing Phase III ovarian cancer study for a biotech company. The study involved approximately 400 patients across 136 sites in 12 countries, requiring adherence to multiple regulatory guidelines and complex trial operations. The previous contracted CRO's lack of responsiveness necessitated Worldwide to expedite the timeline and create custom-tailored solutions to meet the client's specialized needs. The objectives included stabilizing trial operations, ensuring timely study delivery, and improving data integrity. Worldwide successfully mobilized a study team within two weeks and transitioned to a new electronic data capture system, completing patient enrollment on time. The case study details the comprehensive support provided by Worldwide, which included management, biostatistics, medical monitoring, and clinical science, ultimately leading to the successful delivery of the study on time and ready for regulatory submission.