When You Expect the Unexpected, Call PSG for Help!

The review of a Trial Master File (TMF) should be relatively easy, but when we were asked to return to the same CRO four (4) times in a period of six (6) months, we realized that this may not always be the case. The reason for the recurring CRO visits was that, without visiting any of the clinical sites, we kept identifying site-related problems (e.g., missing/lost documents; information discrepancies; translation issues; missing signatures; incomplete Investigational Product accountability records; evidence of inadequate monitoring practices) that were not identified by the CRO in a timely manner. These issues were exacerbated by the CRO’s own ineffective practices, which kept surfacing during our follow-up visits, with respect to 1) document tracking, 2) document version control, 3) information filing and 4) adequate quality review of the TMF contents.

The quality issues that we identified represented a serious business risk to the Pharma company and, as a result, the Pharma company put enough business pressure on the CRO to 1) work with the respective sites to remedy the identified gaps and 2) ensure that the final TMF was ready for regulatory review when it was turned over to the Pharma company. We are glad that the client followed our proposed remediation road map, which greatly increased its chances of getting an FDA approval for its product.