Mount Sinai Heart is one of the world’s leading centers for cardiovascular medicine and advanced diagnostic and therapeutic technologies. The Center for Interventional Cardiovascular Research and Clinical Trials, the academic research center of Mount Sinai Heart, combines the expertise of The Icahn School of Medicine at Mount Sinai faculty and researchers with renowned physicians from around the globe who collaborate to provide the best in interventional cardiology and cardiovascular disease research.
As a leading resource for the prevention, diagnosis, and treatment of cardiovascular disease, our mission remains to improve the heart health of our patients locally and worldwide. Under the direction of Roxana Mehran, MD, the Center has expanded into a full-service clinical trials coordinating center that not only encompasses clinical research expertise but also biostatistical analysis, data management and programming services, and a full range of administrative and support services to help you with implementing your trials.
The Center encourages, supports, and evaluates innovative ideas in cardiovascular medicine. Our center provides leadership with demonstrated quality; physicians with global clinical trial experience who provide clinical trial expertise and advice and serve as Principal Investigators, members of Advisory Boards, Executive Committees, Steering Committees, Clinical Events Adjudication Committees, Data Safety Monitoring Board members, and/or U.S. Food and Drug Administration (FDA) advisors. In addition, our physician experts also provide and advise on: Trial design; Protocol Design; Statistical analytics for trial design; Pre-IDE discussions to support submissions, response, and presentation to the FDA for IDE (Investigational Device) Exemption; Pre-IND (Investigational New Drug); discussions to support submissions, response, and presentation to the FDA for IND; and other FDA interactions as applicable.
As part of our consulting services, our team prepares detailed development plans based upon available data for ensuring project feasibility, sustainability and long term success. Projections and detailed budgets are prepared, building a complete scope of work. The Center for Interventional Cardiovascular Research and Clinical Trials provides a project manager and team to manage all phases of clinical trials from initiation to completion. Our data management group designs, develops and implements electronic solutions to report and conduct innovative research studies. Experts from our biometrics team extract and analyze data and assist authors in effectively presenting results.
The Center provides independent event adjudication (CEC) and Data Safety Monitoring (DSMB) through collaboration with clinical care specialists who are well versed in clinical trial practices, and our team is experienced with medical monitoring and safety reporting. With help from our publications office, we maintain accurate manuscripts, references, slides and figure libraries for investigators and authors.
With successful regulatory filings and trial services for more than 11 countries worldwide, the Center for Interventional Cardiovascular Research and Clinical Trials has a proven ability to administer all aspects of global clinical trial conduct with demonstrated excellence.