FDA Adverse Events Reporting System (FAERS) Data Management Program (DMP) Support Services   2

The U.S. Food and Drug Administration (FDA) intends to award an Indefinite Delivery-Indefinite Quantity (IDIQ) type contract with a 5-year ordering period, for the contractor to process FDA Adverse Event Reporting System (FAERS) reports, submitted by the public, by entering and coding the reports in a timely manner. This process is critical to ensure that the data can be reviewed by the FDA safety evaluation team to identify safety issues and respond to public health incidents to meet its regulatory mission. As a result, the FAERS data management services are required to achieve the results as follows: (1) Collect, receive and process mandatory and voluntary safety reports to make it available to the FDA Safety Evaluation Teams; (2) Establish quality assurance and training programs for the data entry process and management of coding services to enhance the quality of data for the FDA review and analysis; (3) Ongoing review of case processing activities for process improvement and program efficiency. The contractor shall perform these functional DMP services as follows:

1. Performing services within the FDA Standard Operating Procedures (SOP) requirements.
2. Development and enhancement of SOPs.
3. Program management services for the oversight of data management operations, contractor staff training, records management, courier services and regular metrics reports.
4. Receiving data in a variety of physical and electronic formats.
5. Scanning physical documents into electronic formats, reviewing electronic submissions, and making the required corrections.
6. Entering, registering, and processing data into the FDA computer system.
7. Performing data analysis on case processing metrics, tracking services, and stakeholder/user support.
8. Sorting and routing this data to the correct work area or correct FDA Center that regulates the product described.
9. Medical coding of reports using various taxonomies (e.g., MedDRA).
10. Performing quality assurance and quality control on data.
11. Participating in the testing and validation of new software systems used to support new and more efficient data entry systems.