A pharmaceutical company required a proven CRO partner to execute a Phase II study of a novel therapy for acute postoperative pain following bunionectomy. Given demanding start-up timelines, an intensely competitive enrollment landscape, and complex eligibility criteria that place significant pressure on recruitment velocity, the sponsor selected Worldwide Clinical Trials. The sponsor required rapid site activation and continuous operational flexibility to address a screen failure rate that reached 55% at one point, well above the 36% initially anticipated, driven by strict eligibility requirements, perioperative timing constraints, and exclusionary medical histories.
Read the full case study to learn how Worldwide, by combining aggressive recruitment strategies, rapid backup site activation, and rigorous day-to-day vendor coordination, successfully screened 530 patients across five U.S. sites, and delivered database lock within 11 days of the last patient follow-up visit.
