Electronic Data Capture Services

  • Creation of core EDC development documents (like the EDC Development Plan, Study Database Specifications, Logic/Edit Check document, etc.)
  • eCRF Design (in system or mock-ups)
  • Annotated eCRFs
  • User Acceptance Testing (UAT) for eCRFs, dynamics, and logic/edit checks
  • Programming of logic/edit checks
  • Data Import integrations
  • Complete database output validation (forms to screens to database outputs)
  • Standard and Custom Report programming
  • Database modifications
  • IWRS/IVRS Integrations

Study Close Out Services

  • Database Soft-Lock Activities
  • Critical Variable Cleaning
  • Final Database Lock Activities
  • Database Un-lock and Re-lock Activities (should be rare!)
  • Database and Study Record Archival