Three different statistical indicators, statistical significance tests, case reports from literature and much more. Here are the tools of our Business Intelligence.

The SafetyDrugs Business Intelligence module consists of various tools for the analysis of pharmacovigilance data and for signal detection. It was clear to us from the beginning that in order to make an effective and most reliable Signal Detection possible, it was necessary to work on disproportionality indicators.

At first EMA used the PRR (Proportional Reporting Ratio) as disproportionality indicator for its statistics, but recently the Agency suggested the ROR (Reporting Odds Ratio) indicator as the most reliable.
The Signal Detection present in the SafetyDrugs Business Intelligence module is provided with both these indicators, giving furthermore the possibility to use in addition the RR (Relative Risk) indicator. In this way it allows to evaluate different characteristics and, when possible, to overcome the flaws of each indicator.
Moreover for all the three indicators it is calculated the 95% Confidence Interval (95%CI), highlighting both the Lower Value and the Upper Value.
Our analysis of Signal Detection is able to assesst the validity of the sample, thanks to the statistical significance tests χ² (Chi-square) and p-value.

For every Active substance and Adverse Event relation, the module allows to visualize the following data:

  • The number of adverse event (qualitative analysis)
  • The number of cases Unlisted, Unexpected, Serious and Fatal
  • The indicators PRR, ROR, RR and the relative confidence interval PRR(-) and PRR(+)
  • The statistical significance tests χ² (Chi-square) and p-value
  • The reporting of cases arising from Literature.

Moreover thanks to an easy click it is possible to perform a qualitative evaluation going into the detail of each single case, including the Reporter’s and Pharmaceutical Company comments.