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COMPREHENSIVE AE SURVEILLANCE

Dacima’s Adverse Event Following Immunization (Dacima’s AEFI) is a vaccine safety surveillance web application for post-marketing safety surveillance. The module collects information about adverse events (possible side effects) that may occur after the administration of vaccines.

Dacima’s AEFI provides a web platform where adverse events (AE) may be reported, managed, and analyzed. The software includes standard data entry screens for collection of AEs with opportunities to tailor and customize the forms to meet your needs. The software supports options to add automatic MedDRA coding, in addition to links with the ABC tool allowing you to confirm an AEFI diagnosis directly from the DACIMA AEFI software.

FEATURES

  • Standard pre-configured Adverse Event forms
  • Medical Coding
  • Diagnostic confirmation tool (Brighton Collaboration)
  • Real-time data validation, conditional skip patterns and validation checks.
  • Automatic email notifications
  • Dashboards, standard reports and/or custom reports
  • AE status tracking and management features.
  • Electronic signatures.
  • Built-in data clarification forms and reports.
  • Complete audit trail.
  • SAS and SPSS code generator.
  • Data extraction features and options.