Wednesday, May 20, 2009

FDA Posts Presolicitation

The goal for the FDA Sentinel project is to take queries from numerous data sources and provide information quickly and securely for relevant product safety information. The data will be managed by the owner and only the data from organizations who agree to participate in the system will be included. FDA posted the Sentinel presolicitation on May 15th with the intent to issue a Request for Quotations in June.

The scope of work and tasks are to:

  • Provide technical expertise in pharmacoepidemiology and biostatistics to identify, develop, validate, and implement advance analytical and statistical methods related to signal detection, strengthening and validation
  • Provide access and utilize data from disparate automated healthcare data systems including but not limited to electronic health record systems, administrative claims databases, and registries
  • Develop data identification and access plans along with surveillance plans and study designs
  • Test data model options and the effects on signal detection, strengthening and validation
  • Implement standardized data elements in disparate automated healthcare data systems
  • Develop and propose a secure communication strategy to support the data access needs

This announcement is not a RFQ. For more information, go to If interested in the solicitation when released, email Tara R. Hobson, Contract Specialist or call 301-827-9691. The solicitation is scheduled to be available on or about June 1, 2009.