FDA CDER Integrated Data Management

Integrated Data Management is bringing an array of favorable business benefits to CDER including easier data entry, improved data maintenance, tighter interoperability among databases and better overall end user experience. The primary advantage is the improved data quality through the consolidation of databases, which will reduce the number of business processes required and reduce the number of database systems that need to be maintained, potentially resulting in improved utilization and cost savings. The IDM Benefit Cost Analysis predicted an Organizational Cost Savings of $42 million over five years through reducing multiple data management constructs, and offering an integrated infrastructure environment to support CDER's business processes that minimizes interruptions to critical business operations. The IDM BCA predicted an additional Stakeholder Benefit of $480 million over five years, primarily through leveraging automation and scalability to make the Drug submission, analysis, response and inspection processes more efficient. The IDM BCA predicted a Net Benefit of $404 million over five years.

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