Development Strategy

Premier Insight 283 | Rescuing a Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum

Introduction

For those who have been through it, a rescue study transition from one contract research organization (CRO) to another can be a difficult ordeal, often accompanied by logistical hurdles and communication challenges. When a sponsor of a Phase 1 dose expansion trial for a novel oncology therapy contacted Premier Research, they were more than a year into their study, and were seeking a new CRO partner. To successfully transition the study, Premier first and foremost leveraged our robust study transition Standard Operating Procedure (SOP) and associated documents to guide our approach. This, in conjunction with our long-standing expertise in oncology, speedy and flexible contracting, clear study start-up processes, and a proactive engagement to maintain study momentum, allowed us to address client concerns while meeting expanded scope and shifting timelines. The transition was seamless; with Premier enrolling the first patient under our remit within seven weeks of our takeover.

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