A Standard Two-Day Regulatory Audit at a Client's Vendor Turned Out to be a Lot More.

A client asked that we perform a standard two-day regulatory audit at a vendor. The vendor had begun preliminary work for the client, but had not yet generated substantive study-related data.

On the surface, the vendor seemed to be in good shape to support the client: policies and procedures were current and appropriate to the nature of the business, and personnel that were part of the client's project team seemed to have proper training and qualifications. However, cracks appeared as we started reviewing the client-specific records and asking personnel to clarify the details of the process: vendor staff was reluctant to provide information; answers were incomplete and contradictory; vendor personnel seemed disorganized and defensive. Thus did the audit morph into an assessment of whether the vendor can support the client from a business standpoint.

None of the deficiencies observed were of immediate regulatory concern. However, unless corrected, the observed deficiencies would ultimately compromise our client’s timelines as well as the quality of its data. Therefore, we recommended that our client take specific actions designed to ensure that timelines were established and adhered to and that project management and staff were up to the task of supporting the client.

Persisting at looking at just regulatory issues would have resulted in a disservice to our client. Our client was now in a position to save their studies. Just how practical is that?