White Paper

Optimizing Site Readiness in Cell Therapy Clinical Trials Through Comprehensive Support

By Megan Liles, Executive Director, Operational Strategy and Feasibility, Precision for Medicine

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Cell therapies are advanced treatments that must be administered at accredited centers with experience and established quality processes, procedures, and practices to ensure patient safety. As of January 2021, 298 centers have been accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) in the United States and 274 centers have been accredited by the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) in the European Union, though not every center has administered cell therapy.[1],[2]

Research activity in the cell therapy field is brisk, with approximately 1900 studies either ongoing or planned, but the majority of clinical trial conduct is concentrated at established high-profile sites. Developers seeking to accelerate their research may benefit from looking beyond the go-to institutions to lesser-known sites that have the bandwidth, access to patients, infrastructure, and systems to conduct cell therapy studies. Contract research organizations (CROs) with cell therapy experience play a pivotal role in qualifying and supporting these under-the-radar sites to help ensure clinical trial success.

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