The COVID-19 pandemic and cardiovascular issues in clinical trials: Practical and regulatory issues in remote monitoring of cardiac safety

Affiliations

• ¹ WCG-ACI Clinical, Bala Cynwyd PA, USA. Electronic address: [email protected].
• ² Division of Clinical Outcome Assessment, Office of Drug Evaluation Science, Office of New Drugs, Center for Drug Evaluation and Research, US FDA, White Oak MD, USA.
• ³ Boston Scientific, Marlborough MA, USA.
• ⁴ Division of Cardiac Electrophysiology, Diagnostics and Monitoring, CDRH, FDA, White Oak MD, USA.
• ⁵ Division of Cardiology & Nephrology, CDER, FDA, White Oak MD, USA.
• ⁶ BioTel, a Phillips Company, Malvern PA, USA.
• ⁷ ConcertAI, Plymouth Meeting PA, USA.