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The Alliance for Clinical Research Excellence and Safety (ACRES) has announced it will begin offering accreditation of clinical research sites. It reflects the latest development by the Massachusetts-based global non-profit to build a quality-based system to accelerate the development of and access to new medical products.
The accreditation process is grounded in the world's first quality-based global standard for clinical research sites. It realizes the 6-year effort of the ACRES Site Accreditation and Standards Initiative (SASI), carried out by experts in clinical trials from every part of the clinical research endeavor, to encourage, recognize and reward excellence at clinical research sites worldwide.
Led by ACRES VP for Quality Management Systems, Dr. Larry Kennedy, the SASI Team published the first global Quality Standard in The New England Journal of Medicine one year-ago for public review and comment. Since then, the Standard has been revised and pressure-tested at a variety of active research sites, both in the private-sector and academia, while concurrently developing accreditation protocols.
"One cannot over-state the magnitude and importance of what the SASI team has accomplished", noted Kennedy in extolling the collective effort of his colleagues. "Development of a consensus standard and an accreditation process is extremely difficult and time-consuming, rarely if ever accomplished in less than a decade--but this team has done it! Their accomplishment is truly extraordinary."
ACRES co-founder and CEO, Dr. Greg Koski, further praised the SASI Team and Kennedy, saying "When ACRES first announced in Copenhagen nearly a decade ago its intention to create a global accreditation program as the essential foundation for a shared global clinical trials system, few believed that it could, or would, ever be realized. Many have contributed to this effort, but Larry and his team have taken it across the finish line! One should never underestimate the extraordinary power of a small group of true believers working together!"
To house and manage the accreditation process, ACRES has created a specialized internal operating division, the ACRES Site Accreditation and Standards Institute. The Institute will operate within the overall ACRES non-profit framework, but with separate leadership and multi-stakeholder oversight to ensure the integrity and independence of the process. Within the Institute, individual operational units will manage the further development and implementation of the accreditation process itself and the continuing evaluation, updating and expanding of the Site Standard.
Of particular importance is a newly established College of Surveyors. The College will develop criteria for certification of individual surveyors who will work with sites that choose to become accredited and make final recommendations regarding the granting of accreditation. All accreditation will be granted by ACRES, and qualifying sites will be allowed to officially state that they have achieved "ACRES Accreditation," thereby acknowledging their commitment to excellence according to the ACRES Global Quality Standard.
Dr. Mary Westrick, now of University of Wisconsin and formerly of Quintiles, Astellas and Covance, is heading up the College of Surveyors. She notes, "The College of Surveyors is the defender and guardian of the Standard. We will maintain the ethos and philosophy behind the Standard, ensuring that it keeps pace with changing conditions and that we maintain a collaborative and supportive approach to working with Sites. We'll train and credential all Surveyors and we're looking for the best and the brightest to join our Team."
The ACRES Standard was developed in partnership with the British Standards Institution, a global standards organization that has worked extensively in the aerospace and aviation sectors. Sharing an aerospace background with Kennedy, Reg Blake, a co-founder of BSI America, has been instrumental in ACRES work to date and will continue to play a pivotal role. "We have accomplished much, but the greatest challenges lie ahead," said Blake. "A robust process for accreditation must meet the needs of and add value to a diverse, global enterprise."
According to Dr. Freda Lewis-Hall, Chief Patient Officer at Pfizer and a supporter of ACRES efforts to establish accreditation of clinical research sites, "I'm excited to see this come to fruition. Adding site accreditation can make a real difference to patients worldwide as a way to both enhance the development of medicines and get them to the patients who are waiting for them faster."