FAERS Data Management Program Support Services

This Request for Information (RFI)/Sources Sought is for information, planning and market research purposes only and shall not be construed as either an RFP/RFQ solicitation or obligation on the part of the Food and Drug Administration or its Centers. 

The purpose of this RFI is to help the FDA understand industry best practices, technical solutions, and the market’s capability of fulfilling the FDA’s task requirements as described in this RFI. 

FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information.  The information received may be used (for planning purposes) to inform the solicitation.

Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received.  Questions regarding the RFI cannot be accepted.  Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties.  However, the FDA reserves the right to contact vendors if additional information is necessary. 

The primary objectives of this requirement are data management services in support of the CDER Adverse Event Reporting System Data Management Program (CDER-DMP) include:

• Performing case processing of  mandatory and voluntary adverse eventreports submitted to the FDA via the FLARe and FAERS systems.
• Performing data entry services of drug quality reports submitted to the FDA via the FAERS system.
• Maintain quality assurance programs for data entry process and manage coding services.
• Support changes in the data entry process that will lead to greater program efficiency.  For example, this may include updates to processes and software that maintain the accuracy of the data entry process.