Giving Luck a Chance

A pharma company retained The Practical Solutions Group, LLC to assess a major CRO with respect to the CRO's ability to support the company during an FDA inspection. The scope of the assessment included, but was not limited to, availability of study documentation at the CRO, knowledge of study processes on the part of the CRO project staff, validation status of pertinent computerized systems at the CRO, and appropriateness of the CRO's training documentation. In two days, we identified numerous regulatory compliance deficiencies and, more importantly, saw serious issues with the CRO's infrastructure that would limit its ability to provide effective support to our client during the FDA inspection. We provided numerous suggestions to our client regarding what needed to be communicated to, and implemented by, the CRO to maximize success of our client's regulatory inspection. Our client implemented the recommendations and received no FDA-483s. Was it luck or was it a commitment to being as prepared as possible? Speaking realistically, it was a combination of both, but our client would not have been so lucky without our help.