New program accredits clinical research sites globally

31-Jul-2019 - Last updated on 31-Jul-2019 at 14:22 GMT

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Related tags ACRES Clinical trial sites Quality control

Years in the making, ACRES launches a global accreditation program, which will ‘dramatically’ benefit all research stakeholders, including sponsors, CROs, regulators, monitors, as well as patients, says CEO.

The Alliance for Clinical Research Excellence and Safety (ACRES) is a multi-stakeholder collaborative aiming to enhance the quality and effectiveness of drug development.

The organization recently launched a program to accredit clinical research sites, as part of its Site Accreditation and Standards Initiative (SASI), which has spanned the past six years.

Dr. Larry Kennedy, ACRES vice president of quality management systems, led the SASI team, which last year published the first global Quality Standard in The New England Journal of Medicine (NEJM) in partnership with the British Standards Institution.

Since being made available for public review, ACRES has revised and ‘pressure-tested’ the standard at various research sites. As Kennedy, explained, “ACRES is working with early adopters to fine-tune a software interface and to begin development of each accreditation process which includes defining the scope of practice, a self-assessment and gap analysis, and determining what regimens of readiness or preparedness will be required.”

Regarding the pressure testing of the standards, Mary Tobin, PhD, chief strategy officer, ACRES, said the feedback, so far, from those participating has been positive.

“For sponsors and CROs, both the process leading to qualifying for accreditation and being accredited is a standardized means of evaluating a site’s reliability – a process harmonized beyond what sponsors or CROs do individually or even in developing preferred provider relationships,” Tobin said, noting that the process adds value to the entire biomedical R&D ecosystem.

BSI Group America senior vice president, knowledge transfer, Reg Blake, who has been involved in the development of the standard since the beginning, said the standard “aims to protect all clinical research participants globally and replace the existing minimally inspection-based system with a more holistic quality system of processes and risk-based approach."

Kurt Zimmerman, director of the Office of Industry Engagement in the School of Medicine and Public Health, University of Wisconsin, Madison, cited a “cultural shift from regulatory adherence as a driving force to a culture driven by quality.”

ACRES also has formed an internal operating division – the ACRES Site Accreditation and Standards Institute – to manage the accreditation process. Various stakeholders will oversee the institute, which will operate within the ACRES framework, but under separate leadership.

Additionally, the College of Surveyors has been established and is tasked with developing certification criteria for ‘surveyors’ who make the final recommendations regarding site accreditation, all of which will be granted by ACRES.

“An effective global accreditation program will dramatically benefit not only sites, but also every stakeholder who interacts with and depends upon sites – sponsors, CROs, regulators, monitors and patients. Accreditation weaves the fabric of trust upon which all of these parties depend,” said Dr Greg Koski, president and CEO of ACRES.

“The end result is a system-wide enhancement of quality, safety and efficiency at every level, reducing wastefulness, redundancy and delay, fostering innovation, thereby dramatically reducing the time and cost of getting new medicines to the people who need them.”