Site Accreditation & Standards Initiative (SASI)
Accreditation addresses the need for a cohesive, effective approach to promoting and sustaining excellence of clinical research sites, while ensuring that such excellence is recognized and rewarded.
The costs of conducting clinical trials include inefficiencies inherent in the current process, a process that suffers from a lack of uniform standards, interconnectivity and interoperability.
ACRES in partnership with the British Standards Institution has published the first uniform global standards for clinical research sites and independent third-party accreditation. Accreditation promotes professionalism and enhances sustainability while reducing cost and time required to effectively evaluate promising products, supports regulatory oversight and compliance, and also promotes responsible ethical conduct to make new, safe medicines available to patients more quickly with improved outcomes.
ACRES Site Accreditation and Standards Initiative (SASI) Timeline
An implementation approach characterized by multiple accreditation levels related to the risk-level and complexity of trials will allow the broadest range of sites to participate while improving performance and compliance, including small sites conducting only a few trials a year. This also makes the effort much more inclusive, and addresses concerns about barriers to entry for new sites if the standards too onerous.
The approach also incorporates competency-based training and certifying clinical research professionals created by a number of globally oriented organizations and dramatically facilitates implementation of new risk-based monitoring paradigms.
Elements of Effective Accreditation
Collaboration among diverse stakeholders insure that a full-range of multiple perspectives is incorporated in SASI with the most critical common issues being identified and addressed. Accreditation must serve the needs of all stakeholders and appropriately reward those who seek and become accredited.
A Global Model for Effective Site Accreditation
Standardization and metrics increase efficiencies and reduce the costs of running clinical trials. High-performing sites are a valuable resource, and their consistent identification is challenging. Without an accepted, consistent set of standards and accompanying metrics, it is impossible to understand, measure, and compare performance across sites. To achieve consistency of data quality and trial execution, one must evaluate well-defined performance data.Sponsors and patients also benefit from objective quality and safety measures to make decisions about which sites to choose for participation in trials.
SASI: A Comprehensive Process
The ACRES Global Network will include thousands of affiliated sites of excellence, sites committed to adoption and application of standards and technologies that will facilitate their workflow optimize performance and enhance their sustainability and professionalism. This network of accredited sites, with professional clinical research teams and facilities all over the world, will be a valuable resource within a global system that recognizes and rewards their excellence and commitment.