ICSR (AE/SAE) Processing

 

One of our major strengths is to provide ICSR processing services for you.  

 

1. AE Case Entry (ICH E2B Standard)

  • Event coding (MedDRA)
  • Narratives
  • Labeling assessment
  • QC
  • Case follow-up (query, letter, targeted questionnaires)
  • Case validation
  • Case tracking
  • Customized design of data entry for
    • Risk monitoring
    • Signal detection
  • Aggregate data presentation for aggregate reports
  • Coding convention

 

2. Expedited Safety Reporting (IND Safety Report, SUSAR)

  • Generate narratives
  • Review IB for expectedness assessment
  • Database search and summary for similar events
  • Coordinate timely medical review comments
  • Search Database search and summary for similar event
  • Develop query
  • Process follow-up
  • Maintain ESR log for future IB update

 

3. Medical Safety Review

  • Consistency of case narrative and source documents
  • Medical assessment
  • Event clinical course and outcome
  • Medical diagnosis and supporting information
  • Medical history and concomitant medications
  • Causality assessment
  • Temporal relationship
  • Dechallenge and rechallenge
  • Confounding factors or co-morbidities review
  • Pharmacology and risk factors review
  • Labeling assessment
  • Follow-up and query
  • Database search for similar events
  • Writing medical comments
  • Signal identification assessment confirmation
  • Literature search epidemiology review
  • Develop special database search criteria (SMQs)
  • Review relevant cases in other large safety databases (e.g., US FDA FAERS)
  • Prepare summary of case series

G2 Strengths

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