The SASI Leadership Team
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. We 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.
Briggs Morrison serves as Chair of the SASI board of directors and played a key role
in its formation.
He was a founding member of the ACRES board of directors and is the CEO and a Board Director of Syndax Pharmaceuticals, an MPM portfolio company. Prior to joining Syndax and MPM, Briggs served as Chief Medical Officer and Executive Vice President for Global Medicines Development at AstraZeneca. His career also includes distinguished roles at Pfizer and Merck.
Larry Kennedy led the initiative to write and test the SASI Standard for the Quality Management of Clinical Research Sites and now, in
transition, serves SASI as board member and its
first Executive Director. Dr. Kennedy is the Founder and CEO of the Quality Management Institute and a globally recognized leader in the science
and practice of Quality Management with experience as both a teacher and consultant across multiple industries
and sectors.
Mary Westrick was a domain team leader and was very active in the writing and pressure-testing of the Standard. She now serves as
President of the SASI College of Surveyors and is tasked with maintaining the
culture and ethos of our organization and overseeing its conformity assessment services. Dr. Westrick is a highly experienced clinical research executive and
consultant, having served with distinction at Quintiles, Covance and on the faculty at the University of Wisconsin, Madison.
Penny Jester was very active
in writing the Standard and served as a Lead Surveyor in its pressure-testing. As VP Surveyor Operations she will manage all Surveyor activities
and deployment for conformity assessments, as well as the hiring, training and validation of competencies for all Surveyor Candidates and their subsequent performance reviews. She had a distinguished career at the University of Alabama - Birmingham and directed their university-wide clinical research support program.
Ruth Nemire served in a variety of
key activities while writing the Standard and was a Lead Surveyor in its pressure-testing. Dr. Nemire now serves as
VP Administrative Services and Co-Chair for Systems Integrity. She is responsible for the independent review of all accreditation services to assure their quality, integrity and ethical
compliance. An accomplished senior executive, consultant in clinical research, and university faculty, she is the Dean of the Larkin University
College of Pharmacy.
James Riddle actively participated in the writing and testing of the Standard as he Chaired, in parallel, the Accreditation Protocols Domain,
gathering and preparing for publication the essential information that will guide Accreditation Candidates through the certification process. James
serves as Vice President for Institutional Services at Advarra and has had a distinguished career developing and implementing innovative services for
academic medical centers, research universities, and health systems.
Beth DiGiulian helped write the SASI Standard and managed the documentation required for validating its edits. She
was the coordinator between
the Stakeholders group and the British Standards Institution and continues as Chair of
the Standards Review Domain in SASI. Beth is a Lead Associate with Booz Allen Hamilton with skills in Requirements Analysis, Agile
Methodologies, Databases, Healthcare Information Technology (HIT), and Healthcare.
Reg Blake represented British Standards Institution during the writing of the SASI Standard and was very active in providing the perspective required for international acceptance. He now continues as a special consultant in conformity assessment and accreditation. His broad expertise in standards has added significant value to the Standard, its place in the pharma ecosystem and its potential impact on Sites and their constituencies.