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
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
Yale Cardiovascular Research Group
1 Church Street, Suite 330
New Haven, CT 06510, USA
Alexandra Lansky, MD
Director, Interventional Cardiovascular Research
genae associates nv
2018 Antwerp, Belgium