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Last updated on April 18, 2014 at 17:24 EDT

Yale Signs Collaborative Agreement with genae

October 11, 2013

NEW HAVEN, Connecticut, and ANTWERP, Belgium, October 11, 2013 /PRNewswire/ –

Yale University, Yale Cardiovascular Research Group (YCRG), a world-renowned Academic
Research Organization (ARO) and genae associates nv, a global Contract Research
Organization (CRO) and services provider for the medical device industries today announced
they have signed a collaboration and co-marketing agreement.

YCRG and genae will formalize various platforms to facilitate collaboration including
cross-marketing and referral of services to each other, co-facilitation of liaison with
regulatory and governmental bodies and co-deployment of staff, facilities and other
resources.

The collaboration will enable expanding the ARO and CRO services across the value
chain of research from pre-clinical to clinical evaluation and beyond. YCRG and genae will
increase market reach by sharing and sub-contracting monitoring, regulatory, safety, core
laboratory, data management and statistical analysis services.

YCRG Director Dr. Alexandra Lansky has served as the principal investigator for
numerous trials investigating novel cardiovascular devices and adjunctive pharmacology,
and has led the core laboratory analysis of more than 500 clinical trials.

“The growing demand for high-quality but cost-conscious clinical research faces
technological, economic and regulatory change”, said Dr. Lansky. “This unique ARO/CRO
collaboration takes advantage of the opportunities of sponsored clinical trials to advance
scientific understanding and to promote a broad application of evidence-based medicine
that will ultimately benefit patients. It combines the need for academic vision and
guidance with the need for partners that have an entrepreneurial approach, scalable
capabilities and financial backing to invest for the future.”

“I am absolutely thrilled about this collaboration. Cultural alignment and
understanding each other’s expectations to ensure agreement on processes and metrics are
the brick and mortar of true partnerships with our medical industry partners”, said Bart
Segers, CEO at genae. “This ARO/CRO governance model guides the relationship from a
strategic and operational point and helps to build long-term, trust-based relationships at
multiple levels across the organizations.”

About Yale Cardiovascular Research Group

The Yale Cardiovascular Research Group (YCRG) is an ARO that provides independent
resources for the conduct of cardiovascular clinical trials and clinical
evaluation/scientific program development activities. YCRG serves as a regulatory
interface and provides comprehensive clinical trial development and management services.
Clinical research and device development experience includes First-In-Human, regulatory CE
Mark and IDE/IND phase II and III trials, and post market and investigator-initiated
clinical programs. The YCRG core laboratory provides state-of-the art imaging
interpretation and endpoint measures in multiple modalities.

Yale University is a nonprofit corporation organized and existing under and by virtue
of a special charter granted by the General Assembly of the Colony and State of
Connecticut.

Please visit: http://cardio.med.yale.edu/clinicalresearch

About genae

genae is involved in the development and commercialization of medical devices,
biologics and therapies that change medical practice.

genae is a full service CRO and an innovative services provider for the medical
industries and aims at improving health and quality of life by innovating and accelerating
high quality research. The group is ISO 9001 certified for clinical trial management, data
management, statistical analysis, safety, regulatory, core laboratory and medical writing
services for the medical industries.

genae associates nv is a privately held company with principal offices in Antwerp,
Belgium.

Please visit: http://www.genae.com

        Contact

        Yale Cardiovascular Research Group
        1 Church Street, Suite 330
        New Haven, CT 06510, USA
        Alexandra Lansky, MD
        Director, Interventional Cardiovascular Research
        alexandra.lansky@yale.edu

        genae associates nv
        Justitiestraat 6B
        2018 Antwerp, Belgium
        Bart Segers
        CEO
        bart.segers@genae.com
        +32-3-290-03-06

SOURCE genae associates nv


Source: PR Newswire