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

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Notice ID: 75F40123R00015
Related Notice: DAO6152201

Description

The contractor shall perform these functional DMP services as follows:

  • Performing services within the FDA Standard Operating Procedures (SOP) requirements.
  • Development and enhancement of SOPs.
  • Program management services for the oversight of data management operations, contractor staff training, records management, courier services and regular metrics reports.
  • Receiving data in a variety of physical and electronic formats.
  • Scanning physical documents into electronic formats, reviewing electronic submissions, and making the required corrections.
  • Entering, registering, and processing data into the FDA computer system.

6.0 DMP Task Areas The contractor shall meet the following performance-based objectives within each of these functional task areas and further described below.

  • Task Area 1: Case Processing Services Following the Standard Operating Procedures (SOP)
  • Task Area 2: Management of the SOPs
  • Task Area 3: Case Processing Management
  • Task Area 4: Systems & Management Support
  • Task Area 5: Document Delivery (Local Courier Services)
  • Task Area 6: Program Management Services
  • Task Area 7: Data Quality Assurance and Training
  • Task Area 8: Support of FAERS DMP Program Enhancements and Efficiencies

Read more here.

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