Pharmacovigilance

Signal surveillance activities

Ashfield Pharmacovigilance has been afforded the opportunity to work with the world’s leading pharmaceutical organizations to help form our industry-recognized signal detection and management best practices. Our information technology strategy incorporates the latest thinking in next generation data mining, analysis and information delivery. Ashfield Pharmacovigilance’s own Signalytics® program allows for concise identification, workup, evaluation and communication of all signals.

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As a part of Ashfield Pharmacovigilance’s signal detection program, you have access to our Safety Evaluation Committee (SEC). The SEC is comprised of Ashfield Pharmacovigilance’s Chief Safety Officer, highly experienced safety physicians, medical writers and representatives from global aggregate reporting. The SEC is responsible for lifecycle signal detection and analysis as well as recommendations and proposals to clients regarding findings and additional analysis.

The Ashfield Pharmacovigilance signal detection program consists of the following tiered approach:

  • Tier 1: Routine proactive signal identification, prioritization, analysis and reporting
    • Daily medical analysis of serious ICSRs
    • Safety signal tracking and trending over periodic intervals as defined by product risk and client preference
    • Production of formal analysis reports
  • Tier 2: On-demand proactive signal detection and data mining
    • Utilize external passive reporting databases (AERS and WHO Vigibase) for disproportionality analysis
    • On-demand access to the Safety Evaluation Committee (physicians, epidemiologists, pharmacists, biostatisticians, etc.)
    • Weekly SEC meetings to discuss and strategize emerging potential signals from aggregate analysis
    • Qualification and quantification of data
    • Safety data review of reports
  • Tier 3: Strategic risk management planning
    • Development of risk management and communication plans
    • Risk minimization action plans

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