|PRA Health Sciences appoints senior FDA official to lead new Global Center of Excellence for Decentralized Clinical Trial Strategy|
|By GLOBE NEWSWIRE|
|Thursday, 19 November 2020 11:02|
RALEIGH, N.C. , Nov. 19, 2020 (GLOBE NEWSWIRE)
RALEIGH, N.C. , Nov. 19, 2020 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ: PRAH) announced today the appointment of Isaac Rodriguez-Chavez, PhD, MHS, MS, as Senior Vice President, Scientific and Clinical Affairs. He will lead the company’s Global Center of Excellence for Decentralized Clinical Trial (DCT) Strategy. Dr. Rodriguez-Chavez’s responsibilities will involve the continued growth and development of PRA’s industry-leading decentralized clinical trial strategy, regulatory framework creation, and clinical trial modernization.
Dr. Rodriguez-Chavez has more than 32 years of experience in virology, microbiology, immunology, vaccinology and viral oncology, including basic, pre-clinical and clinical research (phase I-IV). Most recently as a Senior Officer for Clinical Research Methodologies, Regulatory Compliance, and Medical Policy Development with the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), he led the development of guidance around decentralized clinical trials using digital health technologies. With the FDA, he evaluated and modernized clinical research protocols that impact multiple disease areas.
“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 Chief Executive Officer 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.”
“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,” said Dr. 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.”
Prior to his work with the FDA, Dr. Rodriguez-Chavez was founder and CEO of 4Biosolutions Consulting and was the Vice President for Research at the Texas Biomedical Research Institute. Before that, he was the Director of the AIDS & Immunosuppression Program at the National Institute of Dental and Craniofacial Research, National Institutes of Health (NIH). Dr. Rodriguez-Chavez also held the position of Senior Clinical Scientist at Schering Plough Corporation and the Director of a portfolio for HIV Vaccines at the National Institutes of Allergy and Infectious Diseases, NIH.
Dr. Rodriguez-Chavez also serves the clinical research community in many capacities, including:
Dr. Rodriguez-Chavez has a B.S. in Biology (Venezuela), M.S. in Microbiology (Venezuela), M.H.S. in Clinical Research (Duke School of Medicine), and a Ph.D. in Virology and Immunology (University of Delaware).
PRA’s Global Center of Excellence for Decentralized Clinical Trial Strategy
“Our focus for many years has been creating an innovative mobile healthcare ecosystem to be able to deliver decentralized clinical trials on behalf of our clients and sponsors,” said Kent Thoelke, Executive Vice President and Chief Scientific Officer at PRA. “We are thrilled to have Dr. Rodriguez-Chavez join PRA to lead that effort within our Global Center of Excellence and use his regulatory expertise to help PRA ensure clinical research is a care option for all patients.”
In just the past year, PRA has put those investments into action, guiding sponsors and partners in the development of decentralized and hybrid clinical trial strategy, protocol development, and securing regulatory approval. PRA has set the standard for the planning and execution of technology integration into clinical research and decentralized trial-focused milestones including:
The Global Center of Excellence for Decentralized Clinical Trial Strategy brings together the expertise of PRA teams who have the practical experience to quickly implement effective solutions that sponsors need when implementing decentralized or hybrid trial designs. For more information about PRA’s decentralized trials capabilities and solutions, please visit https://prahs.com/decentralized-clinical-trials.
About PRA Health Sciences
PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.
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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8b9eff95-a2d6-4284-bf0d-8bd680b5098c