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The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency's Sentinel Initiative.
Rockville, MD (Aug. 11)-The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency’s Sentinel Initiative. In a request for quotations (RFQ), FDA said the assignment requires a contractor to analyze the following qualities of each data source:
FDA will expect the contractor to make specific recommendations about the most promising data sources and environments after it has completed its analysis.
The agency also issued an RFQ to find a contractor that would find and evaluate signal-detection methods to support the Sentinel Initiative. According to the document, the contractor will be asked to analyze methods according to the following criteria:
The Sentinel Initiative aims to create a national, electronic distributed network that improves FDA's ability to monitor drug products’ postmarket performance. As currently envisioned, the initiative will give the agency access to data sources such as electronic health-record systems, Medicare data, and medical-claims databases. The Sentinel Initiative will be created through a public–private partnership that includes government agencies, data holders, academia, patients, consumers, and healthcare professionals.
Quotations for both RFQs are due on Sept. 2, 2008. FDA plans to award contracts on Sept. 18, 2008.
For more about the Sentinel Initiative, see “FDA's Sentinel Initiative Will Improve Adverse-Event Tracking.”