“Quality is the result of a carefully crafted cultural environment. It has to be the fabric of the organization, not part of the fabric.” (Philip Crosby)
The Benefits of SASI Accreditation
The SASI-QMS:2023-2 Standard has been developed to aid the user in developing an effective Quality Management System that is overarching all CRS activities. It is grounded in GCP and focused on quality management fundamentals that create a QM culture of competence and conscience. It can then produce reliable data, effectively mitigate risk, continuously improve, and sustain compliance.
The Clinical Research Site Accreditation is designed to certify the QM culture, assess the QM system, and systematically verify that these essentials are being sustained. The value proposition includes assuring the protection of all clinical trial participants as a fundamental of the CRS operational requirements. The ultimate goal is to make certain that the results of any clinical trial are valued and valuable. Accreditation of conformance to the SASI Standard is intended as the basis for accountability in research wherever, whenever, and for whatever purpose the research is conducted.
SASI has not sought nor received an official comment from the FDA, NIH, etc. However, we have had meetings
intended to inform these agencies of SASI's program and interests. The attached article from Center Watch does indicate that the FDA's
interests and concerns for quality reflect those of SASI.
|The Benefits of Accreditation
|Establish world-class clinical research quality branding with regulatory agencies, commercial and government sponsors and partners as well as peers. Attract top talent and became a market leader.
|Site effectiveness and credibility that is based upon measured, tested, evaluated and confirmed Quality Management systems and procedures that produce reliable data and marketable outcomes.
|Leveraging Trial Enrollments with promises of safe, effective trial management by an Accredited Site that will produce reliable trial data with global impact
|Reducing operating expenses by as much as 20% by eliminating errors, omissions, re-work and lost time and energy for oversight and compliance.
|A path to creating a Quality Culture that is stable and a magnet for recruiting high-performers. Lowers the chaos and expense of staff recruitment and turnover.
|A defined roadmap with answers to "what, why, and how," with participation in a collegial Candidate Forum, Site self-assessment, and readiness coaching.
|Risk-based Quality Management made certain with reliable methods and training resources for leveraging site-specific process derivatives into accurate risk assessments and mitigation procedures.
|Clearly realized gains in compliance, efficiency, productivity, improvements in sponsor negotiations and financial strength, and the ability to sustain growth with a reliable work culture.
|A collaborative, supportive and educational Review and Accreditation process with expert advice and training resources provided.
|A lowered burden on staff and operational resources with flexible planning, scheduling and reviews customized to each Site’s needs.