Case Study

For Cause Investigation Of Potential Fraud And Misconduct At Clinical Research Sites

GettyImages-1461321266 investigation

The owners of a research company had suspicions of fraudulent activities involving senior management and investigators at one or more of their organization's sites. In response to these concerns, they reached out to Advarra® Consulting to initiate a for-cause investigation into possible misconduct and fraud.

Advarra Consulting formulated a for-cause investigation strategy that emphasized compliance with the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines, as well as adherence to U.S. federal regulations, specifically 21 CFR Parts 11, 50, 54, and 312. The investigation also focused on ensuring data integrity and verifying the enrollment of subjects in the clinical studies as claimed.

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