Press Releases and Items of Interest
Read-Download the SASI-QMS:2023-2 Standard
University of Wisconsin - Madison Announces Clinical Trials Institute and Seeking SASI Accreditation
A major academic medical center in the Midwest has established a centralized hub for the development of more collaborative, streamlined, effective and efficient processes in the administration and operation of clinical trials at UW-Madison and UW-Health. The new Clinical Trials Institute represents the coming together of UW Health and the UW School of Medicine and Public Health to advance health care innovations via clinical trials at UW-Madison. Led by Betsy Nugent, this initiative isn’t done in a vacuum. . . . Read More
Quality, Quality, Quality: FDA Official Outlines the Quality Systems It Wants to See in Trials
Quality culture is not just an industry buzzword; it’s incredibly important to the FDA, and the agency is intent on embedding it in clinical trials. David Burrow, director of the FDA’s Office of Scientific Investigations (OSI), said “Nobody wants FDA to inspect quality into a system. That’s like the kidney stone of regulatory oversight. It’s the most painful way forward possible.” It’s “way, way better to build quality in, take care of yourself in the long run and actively choose to avoid the model of inspecting quality into clinical research” . . . Read More
ACRP Introduces Clinical Research Quality Manager (CRQM) to Prepare Sites for a Cutting-edge New Accreditation to Bolster Safety, Quality & Productivity
TrialSite News, March 4, 2020: With changes to ICH E6 R2, including the need for risk-based analysis, planning, and mitigation at the research site level, the Association of Clinical Research Professionals (ACRP) recently announced the adoption of the Clinical Research Quality Manager (CRQM) credential under a new partnership with the Quality Management Institute (QMI). CRQM-credentialed professionals are eligible to become SASI Site Surveyors and play key roles in the Site Accreditation program. . . . Read More
ACRP Adopts Clinical Research Quality Manager (CRQM) Credential in Partnership with QMI
February 25, 2020: The Association of Clinical Research Professionals is adopting the Clinical Research Quality Manager (CRQM) credential under a new partnership with the Quality Management Institute (QMI). CRQM-credentialed professionals are eligible to become SASI Site Surveyors and will play key roles in SASI Site Accreditation. . . . Read More
SASI and the Quality Management Institute Partner for Clinical Research Site Accreditation
September 29, 2019: In furtherance of their shared mission to enhance medicines development and clinical research performance and through an integrated systems approach, two independent corporate entities, Site Accreditation and Standards Institute (SASI) and the Quality Management Institute (QMI) have committed to working together . . . Read More
ACRES Volunteers Create Successor Organization "SASI" to Fulfill Clinical Research Accreditation Regimen
September 20, 2019: The purpose of this tax deductible non-profit organization shall be to engage in any lawful activity for which corporations may be organized under the General Corporation Law of Delaware. In addition the purpose of this non-profit organization is: In recognition of the legacy of the Alliance for Clinical Research Excellence and Safety (ACRES) and in furtherance of its mission to enhance medicines development and clinical research performance . . . Read More
ACRES Testing to Validate the Standard for the Clinical Research Site Accreditation Process
October 2, 2018: The Alliance for Clinical Research Excellence and Safety has begun the process of validating the first global standard for clinical research sites and testing the process for voluntary accreditation of sites. The first evaluation effort, under the direction of Dr. Larry Kennedy, ACRES VP for Quality Management Systems and Chief Quality Officer, is underway in association with ActivMed Practices and Research, Inc. . . . Read More
ACRES Unveils Global Quality Standard for Clinical Research Site Accreditation
July 17, 2018: The Alliance for Clinical Research Excellence and Safety (ACRES) announced in the New England Journal of Medicine the release of a global quality standard for clinical research sites. This release follows the recommendation for voluntary accreditation of clinical research sites to enhance quality and performance in multi-center clinical trials . . . Read More
New England Journal of Medicine Article - Accreditation for Clinical Research Sites
June 28, 2018: Accreditation is used in many fields, including education, travel, construction, and health care. When implemented correctly, it improves quality, performance, and safety, while signaling to the public that an accredited entity is committed to an agreed-on set of values . . . Read More
ACRES and the Quality Management Institute Launch Quality Continuum for Clinical Research Sites
December 12, 2017: The Alliance for Clinical Research Excellence and Safety (ACRES) President and CEO, Dr. Greg Koski, and Dr. Larry Kennedy, Founder and CEO of the Quality Management Institute (QMI), announced that the two organizations will unite efforts to build and deploy a comprehensive professional quality management systems environment to enhance performance, safety, and efficiency across the health care and sciences ecosystem . . . Read More