Novella Clinical, Cardiovascular Research Foundation collaborate, provide clinical trial expertise
Novella Clinical, a Quintiles company, and the Cardiovascular Research Foundation (CRF), an independent, academically focused nonprofit organization based in New York, have announced a preferred provider collaboration that will offer a set of clinical trial services to developers of cardiovascular drugs and devices.
Novella, a full-service CRO with headquarters in Morrisville, N.C., with specialization in cardiovascular medical device research, and the CRF Clinical Trials Center, the academic research organization (ARO) of CRF with its extensive group of cardiovascular physicians and core labs, will work together to provide sponsors comprehensive clinical research services from preclinical to post-market studies.
Novella and CRF will offer sponsors best-in-class study design and execution, with access to interventional cardiologists, CRFiCOR, the Clinical Trials Center’s (CTC) cardiovascular imaging laboratories and Novella’s clinical trial operations experience and medical device expertise. The two organizations will collaborate on protocol development, trial design, statistical analysis, Clinical Events Committee (CEC)/Data Safety Monitoring Board (DSMB) services, clinical monitoring, data management, product safety, project management and quality assurance.
“By bringing together the strengths of both a CRO and an ARO, we will be able to offer superior clinical research services, combining operational excellence with scientific and academic leadership of the highest caliber,” said Ori Ben-Yehuda, M.D., FACC, executive director of the CRF Clinical Trials Center. “We expect, over time, to further develop this collaboration with the introduction of a delivery model where sponsors are viewing trial progress in one portal, under one project manager, providing seamless delivery across joint services.”
Novella and CRF have a track record of effective collaboration and currently are involved in a number of joint global cardiovascular device studies. The two organizations also share a firm commitment to improving the lives of those impacted by cardiovascular disease.
“Cardiovascular disease is the leading cause of death worldwide, and advances in science are being made at unprecedented rates,” said Richard Staub, Novella president. “As experts in cardiovascular clinical trial design and execution, Novella and CRF are seizing this opportunity to leverage our combined expertise and provide sponsors with direct access to today’s leading physicians and dedicated clinical research teams to advance the next generation of cardiovascular therapies.”