The Biomedical Research Alliance of New York (BRANY), a national organization providing expedited end-to-end solutions for clinical trials support to sponsors and investigators, and the nonprofit Alliance for Clinical Research Excellence and Safety (ACRES), have announced a strategic alliance.
One of its first initiatives is a collaboration to develop and test standards for clinical research sites and principal investigators as part of the ongoing ACRES Site Accreditation and Standards Initiative (SASI).
BRANY, founded in 1998, includes NYU School of Medicine, Montefiore Medical Center, Mount Sinai School of Medicine, North Shore-Long Island Jewish Health System and a network of more than 200 affiliated clinical research sites.
“BRANY and ACRES have a shared interest in developing and promoting standards that will enhance the quality and efficiency of clinical trials and protect clinical trial participants,” said Kimberly Irvine, CIP, executive vice president and chief operating officer of BRANY. “Our organization has been offering research site certification as part of its vetting process for years, and this has helped research sponsors and CROs more easily identify high-performing research sites and principal investigators for their studies.”
The two groups said although there are comprehensive laws, regulations and guidelines covering virtually every aspect of running and managing clinical trials, third-party accreditation has not been used effectively to ensure the highest standards for research sites and investigators. Research sponsors and CROs are increasingly relying on centralized vetting processes to identify and select sites. An effective site-oriented accreditation process will facilitate this by recognizing and rewarding excellence.
“ACRES is a collaborative effort to build a global system for clinical research that serves the interests of all stakeholders,” said Greg Koski, Ph.D., M.D., president and co-founder of ACRES. “A fundamental requirement of this systems approach is to develop uniform, comprehensive standards to promote professionalism and operational excellence at clinical trial sites worldwide.”