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www.fdanews.com/articles/169546-cro-foundation-to-offer-cardiovascular-device-trial-services

CRO, Foundation to Offer Cardiovascular Device Trial Services

January 14, 2015

Novella Clinical and the Cardiovascular Research Foundation are teaming up to offer clinical trial services to cardiovascular device developers, the groups said Monday. Novella specializes in cardiovascular device research, while CRF’s Clinical Trials Center has an extensive group of cardiologists and core labs that can assist sponsors from preclinical research through postmarket studies.

Together they will offer best-in-class study design and execution, world-class cardiologists, CTC’s imaging labs and Novella’s expertise in devices and clinical trial operations, the firms said. They will collaborate on trial design, statistical analysis, clinical monitoring, data management, product safety and management, quality assurance and Clinical Events Committee and Data Safety Monitoring Board services.

CTC Director Ori Ben-Yehuda said that over time, the organizations expect to expand the collaboration by introducing a seamless delivery model that lets sponsors view ongoing trials in a single portal, under one project manager. — Kellen Owings