Satisfying Requirements of a Corporate Integrity Agreement

Satisfying Requirements of a Corporate Integrity Agreement

Pharmaceutical Company operating under a CIA

Product: VerifyCE


The client was under a CIA as a result of the actions of a company which they acquired a few months prior.  The CIA required the company to provide documentation to regulators demonstrating that their non-promotional CME grant process and subsequent funded activities were free of commercial bias.  

Key: Objective Data 

Why CME Peer Review :

The client chose CME Peer Review because they needed a group that could provide objective, independent data to the regulators that was valid, reliable and credible to avoid potential scrutiny about internally-generated data.  They also needed a group who had conflict-free subject matter experts with the medical expertise to provide clinical evidence to support their conclusions.  


The compliance department provided CME Peer Review with a list of all company-funded CME activities that were scheduled to occur throughout the calendar year.  From that list, CME Peer Review selected samples of various types of activities including both live and enduring. They audited each of these activities according to parameters provided by the compliance department and consistent with the CIA requirements for documentation.  


CME Peer Review’s extensive and thorough audit, including the large sample sizes of various activities and the robust documentation of the findings provided the level of detail to more than satisfy the reporting requirements of the CIA.   


The client initiated a contract with CME Peer Review to provide the objective, independent data required to satisfy the CIA requirements over the 5-year life of the CIA.  The burden of ensuring and documenting CIA compliance was satisfied through a partnership with CME Peer Review.