PRA Health Sciences appoints senior FDA official to lead new Global Center of Excellence for Decentralized Clinical Trial Strategy
Dr. Isaac Rodriguez-Chavez brings vast expertise in regulatory compliance and clinical research methodology to PRA’s industry-leading DCT practice
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:
- Board Member of the Scientific Leadership of the Digital Medical Society (DiME)
- Regulatory Advisor of the Institute of Electrical and Electronics Engineers (IEEE), focusing on initiatives on decentralized trials using digital health technologies
- Leadership Council member of the Decentralized Trials & Research Alliance (DTRA)
- Board Member of the Hypertrophic Cardiomyopathy Association (HCMA)
- Published 50 scientific and technical articles in his areas of expertise
- Speaker at 68 global conferences
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
The appointment of Dr. Rodriguez-Chavez is the culmination of more than five years of investment in people, processes, and technology to build the Global Center of Excellence for Decentralized Clinical Trial Strategy, the industry’s most robust and integrated clinical research consultancy.
“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:
- In addition to activating more than 50 hybrid clinical trials involving novel digital health technologies over the last three years, PRA launched the first-ever completely decentralized, mobile, indication-seeking clinical trial for heart failure in November 2019. Participants in the ongoing trial are able to engage using their phones and computers right from their own homes. The study uses PRA’s Mobile Health Platform and smart, wearable technology to assess its participants’ quality of life and track their physical activity.
- PRA expanded its Mobile Health Platform in March 2020, allowing sponsors to do everything that is possible at a clinical site, remotely. The platform includes a mobile app available to both sponsors and participants for use when engaging in clinical trials. The mobile app has the ability to gather electronic informed consent and e-signatures, and complete patient reported outcomes — right from the participant’s personal phone or tablet. Using connected devices, the app also can collect home healthcare data and serve it into the source for the clinical trial.
- PRA acquired Care Innovations in January 2020, a leader in consumer-focused telehealth and remote trial participant monitoring. Together, PRA and Care Innovations utilized the Health Harmony app to launch the COVID-19 Monitoring Program in March. The app-driven program allows employers, payers, providers and healthcare systems to track the health and wellbeing of individuals who may be asymptomatic, exposed to SARS-CoV-2 infection or diagnosed with COVID-19.
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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