SASI Vision and History
The Site Accreditation and Standards Institute, Inc. (SASI) is a fully independent Delaware nonprofit corporation operating as a "fee for service" (IRS 509 (a) (2)) organization. Our singular mission is to continue to update the SASI-QMS:2023-2 Standard for the Quality Management of Clinical Research Sites and to deploy and operate a system of Accreditation with a global span.
Accreditation promotes professionalism and enhances sustainability while reducing the cost and time required to effectively evaluate promising products. It also supports regulatory oversight and compliance while ensuring the promotion of responsible ethical conduct to make new, safe medicines available to patients more quickly and with improved outcomes.
The Seeds of Vision Became an Initiative
While SASI maintains its independent management, governance and focused agenda, we recognize the contribution of Dr. Greg Koski, the Founder and CEO of ACRES, who envisioned a global association of professionals and organizations that would reach across the clinical research enterprise with practical, systems-based solutions and the influence to affect meaningful change.
The need for defining a Quality Management System (QMS) and certifying the reliability of clinical research sites (CRS), their leaders, the systems they managed and the reliability of their research data was widely accepted. So there had to be a “Standard” that could be evenly and fairly applied by an independent “accrediting body” that would then propel the global clinical research enterprise into measuring high-performance instead of accepting mediocrity and the occasional embarrassing fraud. And it was to be developed by volunteer professionals called to the Site Accreditation and Standards Initiative (SASI).
The Paradigm Shift from Discussion to Development
SASI became the cornerstone of the vision, but it needed an experienced change leader with a history of managing quality improvement to guide its efforts. Dr. Koski turned to Dr. Larry Kennedy, the CEO of the Quality Management Institute (QMI).
QMI had an established curriculum for creating high-performing work cultures and reliable, quality outcomes.The QMI curriculum was thoroughly vetted by the SASI professionals and adapted to a specialized Clinical Research Quality Manager Certification (CRQM). This enabled the SASI leadership to fully verify and validate the quality management bona fides of the domain teams that would be tasked to write the “Standard.” It would be a Standard for both training and performance, one that would be implemented through a collaborative and educational process of “Accreditation.” SASI’s goal was to enable a CRS Accreditation Candidate to experience something above and beyond the typical “regulatory” experience. It would not only describe “what” needed to be done (as in most international Standards,) but it would provide the CRQM curriculum and training resources to ignite the human motivation for “why” and the practical knowledge and skills for “how.” The Standard would be attainable by any organization, large or small, that was committed to learning, growing and maintaining high quality outcomes.
With the cooperation of the British Standards Institute, a widely recognized leader in writing and certifying Standards, the first global Standard for the Quality Management of Clinical Research Sites was written. While the Standard was quickly recognized as an important milestone by many industry leaders and publications, the SASI Team immediately set about “pressure-testing” the Standard by engaging successful commercial, academic and “hybrid” research organizations, to critically review its clauses under the conditions of a simulated “accreditation” review, and to contribute to the development of the Accreditation protocols.
The Evolution to an Independent Accrediting Body
Dr. Koski’s original idea for a global Standard had grown into a shared vision and a reality. However, it required additional testing and development by the originally envisioned independent “Accrediting Body." The SASI volunteers then created the Site Accreditation and Standards Institute, Inc. (SASI). It had evolved and transitioned from an “initiative” within ACRES to a fully independent “Institute” with the singular agenda of completing the development of the Standard and to construct and implement its accrediting processes. SASI will continually review and update the Standard to keep it relevant in the changing international, regulatory and business climate while maintaining its credibility as a recognizable certification of a CRS’s reliability.