Ensuring the Validity and Accuracy of Data Intended for FDA Submission and Helping to Improve Quality of CRO's Operations. All in a Day's Work.

The Practical Solutions Group was called to the rescue when a client thought they needed a one-day assessment of a system's validation status at a CRO, but instead needed something much more significant. A couple of days before the assignment's date, we learned that there were very specific problems that the client had with the vendor. For example, the data sets collected from the studies were changed without any explanations, some of the values were not medically possible, and some values within the patient dataset were out-of-trend.

The challenge was to address a multitude of identified issues and discrepancies in only one day, as well as to provide respective explanations.

To meet the client's objective, we

1. Turned the audit agenda into an investigation one.
2. Doubled the number of people to conduct the investigation.
3. Requested that the client provide the available information on the issues before our site visit.
4. In advance, supplied the CRO with a list of specific records we would be reviewing.
5. Suggested that the client itself join us in the investigation and assist with assessing CRO's technical answers.

By the end of the day, we identified 3 root causes which, either individually or in combination, resulted in discrepancies noted by the client. One of the root causes was strictly of a business nature, while two others related to the CRO's inadequate regulatory processes and procedures. In addition, after a day's visit, we proposed a practical solution for ensuring the validity and accuracy of the data that was intended for the FDA submission and provided practical suggestions on how to improve the quality of CRO's operations from both compliance and business standpoints.