PRA Health has hired a former FDA clinical research lead to help run its decentralized study unit.
Isaac Rodriguez-Chavez, Ph.D., jumps on board to head up PRA's global center of excellence for decentralized clinical trial strategy. His appointment comes as the global pandemic has sped up the timelines of all CROs in getting an established virtual or siteless approach to study work locked into their business model.
Rodriguez-Chavez comes to the CRO from the FDA, where he was senior officer for clinical research methodologies, regulatory compliance and medical policy development at the Center for Drug Evaluation and Research.
Here, he led the development of guidance around decentralized clinical trials using digital health technologies and also evaluated and modernized clinical research protocols. He joins a long line of former FDA staffers that have left the FDA to work at CROs or biopharma companies, which tap their deep level of expertise in drug development.
“We are honored to have one of the pioneers in decentralized clinical trials and an established expert in clinical trial modernization join PRA Health Sciences,” said Colin Shannon, president and CEO at PRA.
“The clinical drug development paradigm continues to evolve into a more decentralized model to better align with how healthcare is delivered to individuals. By pairing Dr. Rodriguez-Chavez, one of the leading experts in decentralized clinical trials, with PRA’s state-of-the-art DCT platform, we will modernize the clinical trial process.”
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“I am honored to join PRA Health Sciences to lead the Global Center of Excellence for Decentralized Clinical Trial Strategy and enable their implementation with novel digital health technologies,” added Rodriguez-Chavez.
“PRA Health Sciences has the vanguard infrastructure, human capital, and experience to provide excellence in a global suite of clinical research and healthcare services. We are currently experiencing an exponential adoption of modern clinical trial designs in the field, including decentralized clinical trials, and I am truly honored to help lead the change. Importantly, PRA Health Sciences also has the pulse and voice of trial participants and the right approach to assist individuals with their health using the latest innovations in health care systems.”