US-based non-profit the Alliance for Clinical Research Excellence and Safety (ACRES), has formed a strategic partnership with the Biomedical Research Alliance of New York (BRANY) to develop and promote clinical-trial standards.

The initial focus of the alliance will be to collaborate on the development and testing of standards for clinical research sites and principal investigators, as part of ACRES’s ongoing Site Accreditation and Standards Initiative.  

ACRES was set up to foster multi-sector collaborations addressing dysfunctions and inefficiencies in clinical-trial systems. It is working towards a global clinical-research network based on standardisation, accreditation and common information technology.

BRANY provides ‘end-to-end’ support services to sponsors and investigators conducting clinical trials in the US.

Founded by nationally-ranked academic medical centres in 1998, the Alliance now includes New York University School of Medicine, Montefiore Medical Center, Mount Sinai School of Medicine and North Shore-Long Island Jewish Health System, as well as a network of more than 200 affiliated clinical-research sites.

Third-party accreditation

While 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”, the new partners say.

Trial sponsors and contract research organisations (CROs) increasingly rely on centralised vetting processes to identify and select clinical research sites, they note, adding that an effective site-oriented accreditation process “will facilitate this process by recognising and rewarding excellence”.

BRANY and ACRES have a shared interest in developing and promoting standards to enhance the quality and efficiency of clinical trials and to protect trial participants, commented Kimberly Irvine, BRANY’s executive vice president and chief operating officer.

“Our organisation 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,” Irvine said.

Systems approach

A fundamental requirement of ACRES’s systems approach to clinical research is to develop uniform, comprehensive standards that promote professionalism and operational excellence at clinical trial sites, pointed out Dr Greg Koski, the organisation’s president and co-founder.

“Our mission fits perfectly with the philosophy and expertise of BRANY,” Koski added.