About
Who We Are
The world needs clinical research to be accurate, faster, cost-effective and safe. The SASI Standard for Clinical Research Site Quality Management Systems (SASI-QMS) was designed to help research sites achieve these goals. By promoting the use of the SASI Standard and empowering research sites to become fully accredited, we are doing our part to make that happen.
SASI (Site Accreditation and Standards Institute) is a non-profit organization that maintains the SASI-QMS Standard and offers a customizable accreditation program that enables Clinical Research Sites (CRS) to conform to the only global standard for clinical research site quality and safety.
The standard was developed collaboratively by a team of globally recognized experts in clinical trial management and the British Standards Institute. The Standard is based on Good Clinical Practice and conforms to international standards for quality management.
SASI Leadership Team
Briggs Morrison M.D.
Chair of the Board
As a physician leader at Syndax Pharmaceuticals, Merck & Co., AstraZeneca, and Pfizer, Dr. Morrison has overseen the development of numerous biopharmaceutical products in multiple therapeutic areas, from first-in-human trials through to global regulatory approvals. He is currently the CEO of Crossbow Therapeutics and an Executive Partner at MPM Capital. At Pfizer, he oversaw an initiative to implement Pfizer’s Quality Management System, and after seeing the power of these tools, he began working to help make them available to clinical research sites.
Larry Kennedy Ph.D.
Executive Director
Dr. Kennedy is globally recognized in the field of quality improvement and led the initiative to write and test the SASI Standard and develop the Clinical Research Quality Manager (CRQM) Certification. He began as an engineer at NASA working in launch operations and flight crew training, and then as a disciple of Philip Crosby. He has consulted in a wide range of industries to implement quality programs with an emphasis on developing a sustainable quality culture and founded the Quality Management Institute, a supplier of premier on-line quality management training.
Mary Westrick PhD
President of the College of Surveyors
Dr. Mary Westrick has spent most of her professional career conducting early-stage clinical research and managing clinical research sites. She has founded an independent research site, held executive positions in major CROs, and worked for pharmaceutical sponsors, enabling her to appreciate clinical research from a multitude of different perspectives. Mary is a Clinical Pharmacologist by training and has taught Project Management and Leadership in the Master’s program in Biotechnology at the University of Wisconsin-Madison. Dr. Westrick played a significant role in the development of the SASI Standard and now leads the SASI College of Surveyors as its president.
Penny Jester MPH
Vice President of Survey Operations
Working at the University of Alabama in Birmingham for 22 years, Penny developed and directed the university-wide clinical research support program. In that role, she was one of the founding leaders of the comprehensive clinical research education program, and she also oversaw the conduct and management of NIH sponsored international clinical research programs including one 30-site study. In addition to her responsibilities at SASI, she is an adjunct faculty member for The Ohio State University College of Nursing Masters in Clinical Research, and she also has taught GCPs in several low-resource countries. As the Vice President of Survey Operations for SASI, she oversees the hiring, training, and validation of competency for all Surveyor Candidates, as well as manages all SASI Surveyor activities.
Ruth E. Nemire, PharmD, EdD, FCCP, FNAP, CRQM
Vice President of Accreditation Administration
Dr. Nemire is the Dean of Larkin University College of Pharmacy. She is a graduate of Ohio Northern University and the University of Toledo Colleges of Pharmacy, and she completed formal fellowship training in neurology with an emphasis in epilepsy at the University of Miami College of Medicine in Miami, Florida. Dr. Nemire completed a Doctorate in Education with a major in Higher Education Leadership at the Nova Southeastern University Fischler School of Education. She has served as a Senior Vice President of the American Association of Colleges of Pharmacy and was the Founding Dean of the Fairleigh Dickinson School of Pharmacy. Dr. Nemire founded ASK Education Inc, a K-12 competency-based education Company. At SASI, Dr. Nemire was actively involved in developing the SASI Standard, and she currently leads the Accreditation Administration.
James Riddle
Chair, Accreditation Council
James is the Vice President, Research Services & Strategic Consulting at Advarra, and his work focuses on developing and implementing innovative research services for industry sponsors, academic medical centers, research universities, and health system partners. James chaired the SASI committee that wrote the SASI accreditation protocol that SASI uses to assess sites that are seeking accreditation.
Beth DiGiulian
Chair, Systems Integrity
Beth is a Lead Associate with Booz Allen Hamilton with skills in requirements analysis, agile methodologies, databases, cyber security of health IT systems, and Healthcare. She helped write the SASI Standard and managed the documentation required for validating edits. As Chair of System Integrity, she will monitor the Acesis Quality Management Application and the QMI Learning Management System for conformance to international standards for digital systems privacy and security. She will also review internal and external customer satisfaction issues.
Reg Blake
Special Consultant
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.