FDA RFI: FAERS Data Management Program Support Services

Notice ID: DAO6152201

“Project Scope: The Government requires data management support services that include:

  • Receiving data in a variety of physical and electronic formats.
  • Data entry services, data analysis, tracking services, and stakeholder/user support.
  • Sorting and routing this data to the correct work area or correct FDA Center that regulates the product described.
  • Scanning physical documents into electronic formats, reviewing electronic submissions and making necessary corrections.
  • Entering, registering and processing data into FDA computer system.
  • Medical coding of reports using various taxonomies (E. g., MedDRA)
  • Performing Quality Assurance and Quality Control on data.
  • Participating in the testing and validation of new software systems used to support new and more efficient data entry systems.”

“Specific Task Areas: The Government requires a comprehensive solution to satisfying the stated objectives which provide all required services, qualified personnel, material, equipment, tools and methodologies, not otherwise provided and subject to approval by the FDA, to perform the following tasks:

  • Task Area 1: Case Processing Management
  • Task Area 2: Program and Project Management
  • Task Area 3: Training
  • Task Area 4: Support of Updated Software for Greater Program Efficiencies…”

Read more here.

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