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. 

 

1. Signal assessment strategy

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

 

2. 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

 

3. 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

 

4. 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

 

G2 Strengths

  • US Based
  • 24/7 coverage
  • Safety expertise
  • Cost effective
  • Teamwork
  • Compliance-focused
  • Quality-driven
  • Timely turn-around
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