Readiness Assistance from Preferred Service Providers

During the development of the SASI-QMS:2023-2 Standard, its pressure-testing, development of the accreditation protocols, and discussions with early adopters; we discovered essential operating requirements that must be considered to properly control the effective deployment of the Standard and ensure integrity of the Accreditation process. They are:

A) The requirement for a fully independent accrediting organization; and thus, we created the ACRES successor organization SASI.

B) The requirement for comprehensive training in quality management and reasonable measures of a Candidate Site’s sustaining QM culture; and thus, the partnership with QMI.

C) The requirement for competent service providers to help organizations prepare for Accreditation; and thus, we will recognize Preferred Service Providers (PSP).

Rational and Reasonable Steps to Provide Reliable Help

SASI realized it must take responsibility for enabling the availability of sufficient consulting capacity to help all Candidates prepare for Accreditation, whether it be a small, one-site Candidate or a large, complex clinical research system. While it would be easier from a purely ethical/possible-conflict-of-interest viewpoint to allow the marketplace to provide these services randomly and be driven by each vendor organization's commercial motivation, it could also place the entire vision for Accreditation at risk. Because the Standard is an "open" document, third parties providing "implementation" services do not require any licensing or authorization from SASI. And although they would not be able to provide an "accredited" status, their success or failure would directly impinge upon the credibility of the Standard.

To meet this challenge, we have established collaborative relationships with independent but carefully aligned “Preferred Service Providers (PSP)” that are SASI trained and properly oriented to the ethic and ethos of the SASI culture. PSP’s will deliver practical solutions that extend the competencies and capacity of SASI while promoting and facilitating the accreditation process. PSP’s will provide candidate sites with training and resources of the highest quality to assist them in their self-assessment and preparatory efforts – with the caveat that there will be absolutely no promise or link to any formal Accreditation decisions.

We have envisioned and detailed the necessary protections, firewalls and ethical restraints that would protect the credibility of the Standard and allow for the reasonable and stable development of the enterprise. PSP’s will function independently of SASI and will have no contractual obligations or financial interests in its Accreditation processes. A PSP will have no exclusive rights or privileges to provide services on behalf of SASI, but will instead be arms-length facilitators of the consulting, training and implementation services required by Candidates that need well-planned and developed ramp-ups for SASI to recognize their Sites as “Accredited.”