FDA issued a combined synopsis/solicitation on September 2, 2008 to develop and implement an electronic data exchange project. The agency is using technologies to analyze product safety information as part of their premarket risk management effort and the agency is monitoring the safety of medical products after they are approved. Since FDA needs to electronically manage large quantities of product information, the purpose of this project will be to develop an e-platform so that the agency can effectively exchange this data.
FDA issued the synopsis/solicitation to locate an independent consultant capable of exploring, identifying, and analyzing the needs of FDA and the medical products industry, and has the capabilities to develop an information exchange network.
The contractor is expected to deliver a work plan with information on existing organizations that are exchanging clinical research data and other healthcare information, while examining their approaches that succeeded or failed.
In addition, the contractor will need to develop a blueprint for workshops and/or outreach activities that will be needed to evaluate existing models of information exchange in the healthcare sector.
The response date for the synopsis/solicitation “Business Model for Partnerships to Develop and Implement an Electronic Data Exchange Program” ((FDA-SOL-08-EPLATFORM) is September 12, 2008. For more information, go to www.fbo.gov or email Terry.Frederick@fda.hhs.gov or call (301) 827-7043.