Safety Signal Detection

Another strength of our safety team is the ability to provide the high-quality service of safety signal detection for our clients.

Signal assessment strategy

  • Medical concept and risk assessment
  • AE terms grouping
  • Development of targeted questionnaires for AEoSIs

Signal monitoring

  • Real-time risk monitoring for potential safety signals
  • Targeted follow-up for identified Adverse Event of Special Interests (AEoSI)
  • Weekly, monthly or quarterly reviews of safety data/line-listings
  • Integrate review of clinical trials data across protocols or programs

Signal analysis

  • Confounding and risk factor review
  • Review background rates in overall populations (or disease-specific populations)
  • Review drug exposure and estimated reporting rates
  • Understanding safety signals and taking appropriate precautionary measures

Additional risk data search and review

  • External database (e.g., FAERS) review
  • Data-mining for assessment of potential safety issues
  • Review of competitors’ labeling documents
  • Targeted literature review and summary