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Signal Management

Qualitative and Quantitative Analysis for End-to-End Signal Management and Trend Reporting

ClinChoice’s team of physicians employs the most appropriate statistical algorithms for signal identification with diverse experience across multiple therapeutic areas. We mine a myriad of data sources, ranging from spontaneous cases to case series to literature assessments, to external databases (FAERS, Vigibase, and EVDAS, among others) to detect and evaluate potential signals.

We author medically reviewed reports to document the benefit-risk profile and recommendations for any identified signals.

Our services include:

  • Signal Detection
  • Signal Validation and Confirmation
  • Signal Analysis and Prioritization
  • Signal Assessment
  • Authoring of Signal Management Reports
  • Support for Labeling Updates