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.
TORONTO (PRWEB) September 29, 2020
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.
Join Sy Pretorius, M.S., FFPM, EVP, Chief Medical & Scientific Officer, Parexel International, Mary Arnould, Director of Program Management and RBM Lead, Astellas US, LLC and Rebecca D. Kush, Ph.D., Chief Scientific Officer, Elligo Health Research in a live webinar on Tuesday, October 13, 2020 at 1pm EDT.
For more information or to register for this event, visit Understanding and Actualizing DCTs, SDR, and SOAR: Toward a New Paradigm for Research in a Changing World.
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