Understanding and Actualizing DCTs, SDR, and SOAR: Toward a New Paradigm for Research in a Changing World

Decentralized clinical trials (DCTs), which were encouraged by the FDA as a means to modernize clinical trials per the 21st Century Cures Act, have received new interest during the pandemic. Consideration for safety of study participants and clinicians in this changing world demands a new paradigm for research.

DCTs (for which all trial activities are decentralized) or hybrid trials (which have a decentralized component) can be realized through a spectrum of approaches, which Parexel has been supporting in increasing numbers since the start of the pandemic. TransCelerate has defined and explored source data review (SDR) as a means of doing risk-based monitoring, including remote monitoring, with a focus on data integrity and data that are most critical and meaningful. Elligo’s System of Accelerated Research (SOAR®) takes a systems approach to clinical research. With SOAR, DCTs can more readily be actualized through technology-based services and a clinical control layer. DCTs can be customized per protocol while leveraging technology and core processes that place more control closer to the source (i.e., the patient and their physician) such that they are mutually beneficial for sponsors, physicians, and especially their patients.

Speakers

Sy Pretorius, M.S., M.D., FFPM, EVP, Chief Medical & Scientific Officer, Parexel International

Sy Pretorius is Executive Vice President, Chief Medical & Scientific Officer at Parexel and has been with Parexel for more than two decades in a variety of roles and countries. On a day-to-day basis, Pretorius collaborates closely with biopharmaceutical and medical device clients in designing and optimizing drug/device development strategies and plans, as well as finding, evaluating and purchasing assets. As a member of the Parexel executive leadership team, Pretorius is responsible for the overall leadership of a number of Parexel service lines & business units – these include Global Medical Services, Early Phase Clinical Units, Global Site Solutions, Translational Medicine (includes Genomics, Modeling & simulation and Biomarkers, Real World Data Services, Real World Evidence, Safety Services, the Patient Innovation Center, Regulatory Outsourcing and The Medical Affairs Company (Medical Science Liaisons). Pretorius is absolutely passionate about drug development and leads several company-wide forums and initiatives focused on clinical trial innovation and further expanding PAREXEL’s capabilities and service offerings. Pretorius is a Medical Doctor (M.B.,Ch.B) with Masters degrees in Clinical Pharmacology (M.Med.Sc), Business Administration (MBA) and, most recently in the Management of Drug Development (MS) from the University of Southern California (USC). Pretorius has and continues to publish and present extensively. In 2017, Pretorius was recognized as one of the top 100 most inspiring people in the pharma industry by PharmaVoice magazine

Message Presenter

Mary Arnould, Director of Program Management and RBM Lead, Astellas US, LLC

Mary Arnould is Director, RBM Lead, Clinical Science Program Management at Astellas Pharma and has been with Astellas almost 3 years. She has over 25 years of clinical operations and site monitoring management experience, focusing on RBM implementation since 2014. Arnould supported the implementation of RBM at Bristol-Myers Squibb before joining Astellas after a long career in site monitoring. She has been able to apply that experience to the evolution in the risk-based approach implemented at Astellas exploring ways to evaluate effectiveness, promote adaptability, leverage technology, and enhance processes to meet the challenges presented by the current pandemic. Arnould is an active member in the TransCelerate RBM work stream and has had the opportunity to share her experience with RBM implementation over the past few years at multiple conferences including SCOPE, DIA and the Clinical Trial Innovation Summit. Arnould earned a BSN from Ball State University and a MSN from Indiana University.

Message Presenter

Rebecca D. Kush, Ph.D., Chief Scientific Officer, Elligo Health Research®

Rebecca Daniels Kush, Ph.D., is Chief Scientific Officer of Elligo Health Research. Dr. Kush has approximately 40 years of experience in the area of clinical research and related technology, primarily related to process analysis and redesign, global data standards and data sharing, eSource, and bridging the gap between research and healthcare. Dr. Kush is also Founder and President Emeritus of CDISC, which she led for 20 years. She held prior positions with the U.S. National Institutes of Health, academia, a global CRO, biopharmaceutical companies in the U.S. and Japan, and was a Fellow for the Translational Research Innovation Center in Japan. Her publications have appeared in NEJM, JBI, Science Translational Medicine, BMJ, and Springer’s Clinical Research Informatics textbook. Dr. Kush earned her Ph.D. in Physiology and Pharmacology from the University of California San Diego (UCSD) School of Medicine and a B.S. in Biology and Chemistry from the University of New Mexico. She is a founding director on the board of the Learning Health Community and an Associate Editor for the Learning Health Systems Journal. Dr. Kush was appointed to the U.S. HIT Standards Committee and has served or serves on boards for HITSP, DIA, CDISC, NCI, HL7, ACRES, Saama, and Litmus Health.

Message Presenter