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For further information on Signal Detection please see our PDF.

Signal Detection

PV-Works offers a variety of tools to support signal detection ranging from:

  • simple incidence reports by product, clinical sign and time period
  • basic statistical reports showing proportional reporting ratios and Chi-squares
  • through to a comprehensive statistics module that adds bayesian statistics, graphical capability, user-defined alerts, advanced data grouping and many more functions

These can be incorporated into your pharmacovigilance process such that a regular review of safety profiles is conducted as required by regulatory authorities.

It is recommended that this process is fully documented, even if the review detects no changes. Signal detection is likely to be a critical issue during pharmacovigilance inspection.

  • Signal detection options for all sizes of database
  • Incidence count reports for small case volumes
  • Full statistics capability using methods adopted by regulatory authorities