The signal management process at CONTINUUM covers all steps from detecting signals to recommending action(s) as follows:

  • Signal Detection, Validation, Prioritization, Analysis & Assessment

  • Review of Serious Unexpected Associated listings

  • Review of Safety Database Outputs - Listings of mortality, pediatric, elderly, pregnancy, lack of effect, drug interaction, product quality/technical, medication errors, off-label use, hepatic and renal impairment

  • Literature alerts and review

  • Disproportionality analyses such as Proportional Reporting Ratio

  • Guided questionnaires

  • Trend analysis

  • Signal Detection in EudraVigilance (EVDAS) 

Signal Management & Safety Surveillance

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