"An 'intelligent system' is the reasonable pairing of competent, well-prepared humans and technologies to improve outcomes."
(Barclay Brown, Raytheon 2019)
The SASI-IS (Intelligent System) for Accreditation
A “SASI ACCREDITED” CRS has demonstrated conformance to the SASI-QMS:2023-2 Standard. through a comprehensive assessment and a
measurable commitment to the work culture and sustaining processes of a Keeping the Promise Quality Management System and its
organizational, professional, and personal values.
All accreditation reviews are fulfilled by experienced and vetted clinical research and conformity assessment professionals credentialed by the College of Surveyors.
The element of the competent human that can assess the available facts and make good decisions is essential. And with the aid of technologies, we can efficiently gather, aggregate and organize our facts, conserve time, and then create and communicate reliable responses. To that end, our accreditation process is designed to integrate human competencies with technologies in an "intelligent system" for certifying conformance to the Standard.
Our accreditation process is educational, collaborative and supportive; and the process is fulfilled by knowledgeable, experienced and reliable Surveyors that are trained and certified by the SASI College of Surveyors. They will meet with potential Site Accreditation Candidates in free, live-online, on-camera, and confidential conferences to assist in defining the "scope of practice" of the CRS, the specific expenses for Accrediting your Site(s) and, when ready, completing the initial application and Accreditation Agreement.
Read-Download the Accreditation Protocol
Certifying the CRS Quality Management Culture
The CRS can choose to enroll in the SASI Accreditation Exploratory Program or formally apply via an Accreditation Agreement. If the CRS ia confident to proceed via the Accreditation Agreement, the required starting point in the accreditation process is the completion of the online and competency-based training and certification of the Site personnel. The program is designed to enable Site personnel to competently complete a Site self-assessment and write a plan for conformance to the Standard that will conserve time and financial resources while avoiding the unnecessary disruption of Site operations.
The Exploratory Program is supplemented with optional participation in the online KTP Community where lively and highly relevant discussions take place with fellow Candidates, Accredited Sites, and SASI Site Surveyors as each Site's leadership considers their readiness for the Accreditation Review.
Accrediting the CRS Quality Management System
When the accreditation Candidate decides it is ready for the Conformity Assessment to verify and validate that it is in conformance to the Standard, it then uploads into our secure SASI-ware user interface the documents and other evidences that can be reviewed by the SASI Surveyors. This begins an interactive process that includes live and recorded discussions within a specific approval process for each clause of the Standard. This technology-assisted method allows the Candidate to distribute the workload among its available staff and create a flexible schedule of planned interactions with the SASI Surveyors that produces an orderly, efficient and "intelligent" accreditation process.
Maintaining Accreditation Status - Continuing Quality
The Accreditation of a Clinical Research Site is an assessment of its Quality Management System against the Standard of the SASI-QMS:2023-2. The assessment is more than just a snapshot of the CRS’s current conformance to the Standard. It is also an assessment of the viability of the internal processes and work culture required to sustain and improve the Quality Management System over time. The SASI continuing assessments regimen is designed to validate that the Clinical Research Site remains in conformity with the Standard and is enabled to progressively improve and raise its level of practices.