Medical device evaluation, especially for high-risk and implantable devices, is associated with multiple methodological and interpretative challenges. At the DCRI, our expertise in device research spans from Phase I studies through post-market surveillance. Our faculty members and research and operational teams work with experts from industry, government, and academia to conduct device studies in every therapeutic area. For device trials, we offer the following services.
Device Trial Services
- Protocol Development
- Project Management
- Site Management
- Site Monitoring
- Risk-Based Monitoring
- Patient Recruitment and Retention
- Data Management
- Statistical Programming, Analysis and Reporting
- DSMB Oversight and Coordination
- Regulatory Oversight and Compliance
- Medical Writing
- Quality Assurance
Coordinated Registry Network for Devices
The creation of a coordinated registry network (CRN) is a key element in building a national medical device evaluation system, according to a new editorial by the DCRI’s Mitchell Krucoff, MD.
Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks
The article, co-authored with Art Sedrakyan, MD, PhD, of Weill Cornell Medical College and Sharon-Lise T. Normand, PhD, of Harvard Medical School, appears in this recent issue of JAMA.
MDEpiNet Strengthens Device Surveillance
The Medical Device Epidemiology Network (MDEpiNet) convened the Medical Device Registries Task Force (MDRTF) to strengthen the medical device postmarket surveillance system using existing resources and develop an integrated system to facilitate premarket device clearance and approval.
Mitchell Krucoff, MD
Co-Director, Cardiovascular Devices Group
Director, Electrocardiology Core Lab
Professor of Medicine, Cardiology
Mitchell Krucoff came to the DCRI in 1988 from Georgetown University. In addition to founding the DCRI's eECG Core Lab and directing its interventional device trials, he is a professor of medicine and directs the Cardiovascular Laboratory at the Durham Veterans Affairs Medical Center. He sits on the Board of Directors of the Sri Satya Sai Institute of Higher Medical Sciences in Puttaparthi, India; is senior editor of the Journal of Alternative & Complementary Medicine; and is past editor-in-chief of Alternative Therapies in Health & Medicine. He is a fellow of the American College of Cardiology and the American College of Chest Physicians, and sits on the National Heart, Lung, and Blood Institute's Clinical Trials Review Committee and the U.S. FDA's Circulatory Devices Advisory Panel.
Krucoff's research and clinical interests include acute coronary syndromes, asymptomatic myocardial ischemia, cardiac devices, eECG technologies, and cardiovascular applications of spiritual and complementary therapies.