Let GenInvo’s Solutions Analysts and Anonymization Teams Provide the Support You Need to Meet Your Data Transparency Challenges

SUMMARY/CHALLENGE

A top-10 pharma client had an urgent need to anonymize studies in a compressed timeframe for submission to the EMA. These studies contained both collection and analysis datasets and had documents containing several thousand pages. The client needed a go-to partner they could trust to handle their technical challenges within a very aggressive timeline. They came to GenInvo as an industry leader in data and document anonymization solutions AND services having a track record of successful submissions to the EMA.

Solution offered

GenInvo’s Solutions Analysts quickly assessed the studies’ data and documents using SHADOW™, an industry-leading anonymization solution for both data and documents. Anonymization Plans were efficiently generated detailing the strategies to be used to anonymize the study documents below the EMA’s required risk threshold while maintaining data utility. After approval of the Anonymization Plans, the GenInvo Anonymization Team immediately executed the plans using SHADOW™ to create draft anonymization datasets (leveraging PhUSE guidance) and documents (as “Redaction Proposals”). Even within the tight timelines, the efficiencies of GenInvo’s SHADOW™ solution and the support of GenInvo’s Anonymization Team allowed sufficient time for client review, finalization, and timely delivery of the Anonymization Packages.

Result

The anonymized studies were delivered on time and accepted by the EMA. Having exceeded expectations, the client continues to work with GenInvo for general data transparency guidance and additional, as-needed anonymization project support.