Cardialysis has a solid network of 30+ expert clinicians and investigators including a broad range of cardiovascular specialists such as interventional cardiologists, clinical cardiologists, cardiac surgeons, electrophysiologists, heart failure experts, intensive care practitioners, coronary imaging experts, and neurologists, with an average experience of 15+ years on endpoint adjudication. These CEC members are trained to adjudicate events in compliance with Cardialysis SOPs and the trial-specific requirements described in the CEC Charter. Other adjudicators can be trained at Cardialysis and can join the team of CEC members for a specific trial. Adjudications are mostly performed in English language. However, given the global reach of our CEC member pool, it is possible to adjudicate in other languages without translation of source documents, including: Dutch, French, German, Italian, Japanese, Arabic, Greek, Polish, Danish, Swedish, Norwegian, and Spanish.
Director of Clinical Endpoint Adjudication and Data Monitoring
Dr. Ernest Spitzer, a cardiologist affiliated to the Erasmus University Medical Center in Rotterdam and expert in clinical endpoint adjudication processes and definitions, leads the endpoint adjudication program at Cardialysis. Together with an experienced and precise multi-disciplinary team including up to 30 professionals, the Cardialysis program aims for consistency and robustness in results. At the same time, the SOP-supported process and the in-house software solution for endpoint adjudication (WebCEC 3.0) maintain the integrity and independence during the adjudication process. Dr. Spitzer also represents Cardialysis at the Board of the Academic Research Consortium, where ongoing efforts contribute to standardization of endpoint definitions across cardiovascular clinical trials.