A Business Deal Savior
Inexperienced and/or impractical auditors completing a one-size-fits-all checklist can sometimes generate paroxysms of
... well ... "unpleasantness" on the part of the audited entity. Such was the case when a client (a CRO) underwent a sponsor audit that was performed by a contracted third party. The sponsor was in the process of acquisition negotiations with another company. Therefore, the accuracy and validity of the study's results, collected by our client, were of the utmost importance to them.
The Practical Solutions Group, LLC was asked to get involved when the third-party's audit report unfairly and inaccurately presented our client's capabilities and activities to the sponsor. The responses to the third-party audit observations were the last critical piece regarding making or breaking the deal, especially since the audit resulted in eight
"critical" observations, twenty "major" observations and nine "minor" ones, making the CRO look horrific and putting under question all of the study results.
Using the auditors' inexperience (e.g., lack of specific examples, lack of understanding of the timing of activities) and inappropriate wording (e.g., lack of definitions for concepts like
"comprehensive", "adequate" and "robust") as a starting point, we turned the table on the auditors. Specifically, we advised the client regarding what documentation and records they needed to collect in order to show that 1) the auditors' observations were unsubstantiated and 2) neither the integrity of the study data, quality of the sponsor's product nor the public safety in general (yes
... one of the auditors' contentions was that the public safety was jeopardized due to non-compliance with several SOPs), were impacted. At the end of the day, there were no critical or major observations remaining (i.e., all were rebutted); several minor observations were justified. The sponsor was relieved that every issue was defended and grateful that every observation was skillfully addressed in a way that did not compromise their business deal.
The sponsor's business partner was impressed with the CRO's responses to the audit observations. Based on the quality of the responses, our client ended up with more work from the newly formed entity and we further solidified our reputation for practicality in the eyes of our client. Success for all!