Novella Clinical and CRF collaborate to provide comprehensive clinical trial expertise

January 12, 2015

RESEARCH TRIANGLE PARK and NEW YORK, January 12, 2015 - Novella Clinical, a Quintiles company (Novella), and the Cardiovascular Research Foundation (CRF) today 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 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 best-in-class study design and execution, with access to some of the world's leading 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, MD, 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 are currently 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 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."
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About Novella Clinical

Novella Clinical, a Quintiles company, is a full-service clinical research organization (CRO) with headquarters in Morrisville, N.C. and 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. Founded in 1998, Novella integrates deep clinical and therapeutic expertise, operational excellence, and a superior level of customer service to streamline product development. For more information, visit http://www.novellaclinical.com.

About CRF and the CRF Clinical Trials Center

The Cardiovascular Research Foundation (CRF) 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.

The CRF Clinical Trials Center (CTC) has shaped the cardiovascular field by directing some of the most influential and complex trials in recent decades. For over 20 years, the CTC has contributed to key advances in the treatment of cardiovascular disease and played an essential role in bringing innovative new technologies, pharmacologic therapies, and treatment paradigms to patients. For more information, please visit: http://www.crf.org/clinical-trials-center.

Cardiovascular Research Foundation

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