Case Study

From FPI to Acquisition: Delivering the Phase Ib Data Package That Established a Potential First-in-Class ADPKD Therapy

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A small biotech entrusted Worldwide with its only clinical asset for a complex Phase Ib trial spanning double-blind MAD cohorts and an open-label fixed-dose arm across 18 U.S. sites. The biotech was researching an investigational microRNA inhibitor targeting miR-17, representing a first-in-class mechanism for Autosomal Dominant Polycystic Kidney Disease (ADPKD), the most common inherited cause of renal failure. Worldwide navigated elevated screen failure risk within a genetically confirmed patient population, maintained the integrity of critical biomarker endpoint data through a mid-study central laboratory reorganization, and delivered seamless operational continuity when the sponsor was acquired mid-trial by a major global pharmaceutical company.

Read the full case study to learn how Worldwide managed enrollment, protected submission-ready data, and ensured program continuity throughout a mid-study acquisition.

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