Organizations Collaborate to Provide Advanced Services for Cardiovascular Device Clinical Trials

Novella Clinical, a Quintiles company, and the Cardiovascular Research Foundation (CRF) are collaborating to offer a set of clinical trial services to developers of cardiovascular drugs and devices.

Novella, is a full-service clinical research organization (CRO) 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 distinguished cardiovascular physicians and leading core labs, will work together to provide sponsors comprehensive clinical research services—from preclinical to post-market studies.

Novella and CRF will offer sponsors study design and execution, with access to some of the world’s leading interventional cardiologists, the Clinical Trials Center’s 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 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., 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 currently are involved in a number of joint global cardiovascular device studies.

“Cardiovascular disease is the leading cause of death worldwide, and advances in science are being made at unprecedented rates,” said Novella President Richard Staub. “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.”

Founded in 1998, Novella Clinical is headquartered in Morrisville, N.C. (which is near Research Triangle Park and Raleigh), and has operations in the Americas, Europe and Asia. Novella specializes in serving the unique needs of small and mid-sized oncology companies, and medical device companies of all sizes.

The Cardiovascular Research Foundation is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. For more than 20 years, the CRF Clinical Trials Center has directed some of the most influential and complex trials.