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EY-Global-Forensic-Data-Analytics-Survey-2014

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Big risks require big data thinking<br />

<strong>Global</strong> <strong>Forensic</strong> <strong>Data</strong> <strong>Analytics</strong> <strong>Survey</strong> <strong>2014</strong><br />

Leverage analytics,<br />

mitigate risks<br />

The following section is a collection of case studies across multiple<br />

industries where we have observed clients successfully deploying<br />

the right people, processes and technologies around FDA.<br />

Pharmaceutical company<br />

A leading global pharmaceutical company integrated FDA to assist in compliance<br />

monitoring between their sales representatives (REPs) and the health care professionals<br />

(HCPs) they interact with in certain high-risk countries. Whereas traditional FDA thinking<br />

would consider only one data source for analysis, this company incorporated big data<br />

thinking and integrated multiple structured and unstructured data sources with more<br />

sophisticated applications — in addition to spreadsheet and database applications.<br />

As the model below depicts, the company developed new analytics that incorporate<br />

multiple data sources to “risk rank” both REPs and HCPs across a variety of regulatory<br />

and corporate integrity risks, including fraud, corruption and off-label marketing. Dynamic<br />

monitoring dashboards were provided to local in-country compliance officers and/or<br />

division managers, along with adequate training and instruction as to how to spot trends<br />

and anomalies. Given the increased transparency into the business, coupled with findings<br />

and success stories of rogue employee detection, this FDA program was deployed to<br />

dozens of regions over the course of approximately 18 months.<br />

Figure 22<br />

Multiple<br />

data sources<br />

Meal<br />

interactions<br />

Educational<br />

materials<br />

Speaking<br />

events<br />

Consulting<br />

agreements<br />

Medical info.<br />

requests<br />

Advisory<br />

boards<br />

Product<br />

samples<br />

Physician<br />

interactions<br />

Expert input<br />

forums<br />

FDA<br />

algorithms<br />

Application of testing metrics developed into a<br />

risk-scoring model focused on identifications of<br />

high-risk interactions between REPs and HCPs<br />

REP ranking<br />

model<br />

HCP ranking<br />

model<br />

Monitoring<br />

dashboards<br />

26

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