It’s essential that clinical trial investigators can confidently monitor patient safety and sponsors have confidence that regulators will accept data that is gathered in a remote format.
October 02, 2020
Join a special panel of experts for a live webinar on Friday, October 16, 2020 at 2:30pm EDT.
The past years have seen advancements in remote monitoring and telemedicine. The COVID-19 pandemic has accelerated the movement of healthcare from the hospital and outpatient facilities to the home. This decentralization has also affected the conduct of clinical trials; in July of 2020 FDA issued a final FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.
It is likely that the movement toward remote cardiac monitoring and remote clinical trial visits will continue well past the current public health emergency. As such, it’s essential that clinical trial investigators can confidently monitor patient safety and sponsors have confidence that regulators will accept data that is gathered in a remote format. Therefore, the Cardiovascular Safety Research Consortium has brought together industry experts along with representatives from FDA — from both Centers of Drug and Device Evaluation — in order to explore some best practices for remote cardiac monitoring.
The speakers include:
Fred Senatore, MD, PhD, FACC, Medical Officer/Clinical Team Leader, Division of Cardiology & Nephrology, CDER, FDA
- LT Stephen Browning, BS, Assistant Division Director – Blood Pressure and Flow Devices, Division of Cardiac Electrophysiology, Diagnostics and Monitoring, CDRH, FDA
- Polina Voloshko, MD, Chief Medical Officer, BioTel Research
- Kenneth Stein, MD, FACC, FHRS, Senior Vice President & Chief Medical Officer, Cardiac Rhythm Management and Global Health Policy, Boston Scientific
- Elektra Papadopoulos, MD, MPH, Acting Director, Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA
- Kenneth G. Faulkner, PhD, Vice President, eCOA Scientific Services, eRT
For more information or to register for this event, visit Remote Cardiac Safety Monitoring for Clinical Trials: Through the Pandemic and Beyond.
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