Case Study

Accelerating Approval Pathway for Phase III Ovarian Cancer Trial

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Worldwide helped a late stage biotech rapidly launch a global Phase III confirmatory trial for a rare ovarian cancer therapy, overcoming ultra low incidence, complex diagnosis, and the need for a 100+ site footprint to satisfy accelerated approval requirements. By deploying an expert team and using data driven global site selection with cooperative group support, Worldwide enabled the sponsor to meet aggressive NDA linked milestones and secure FDA approval.

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