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SigTrace

End-to-End Signal Management Tool

SigTrace is a consolidated, end-to-end signal management tool that manages signal detection validation, analysis, prioritization, assessment, recommendation for action and exchange of information. SigTrace integrates directly with the safety database and has a built-in reporting engine to help manage the entire signal management process.

Benefits of SigTrace include:

  • Consolidates all parts of the signal management process (signal evaluation, validation, analysis, prioritization, assessment and recommendation for action) into one tool, providing a clear overview of the entire process
  • Integrates directly with the safety database, providing efficiencies (eliminating manual extraction) and ensures that data used for the signal management process originates from a validated source and is not prone to corruption
  • Semi-automated features for detection, form validation checks, reports and notifications including:
    • Signal validation – workflow to decide if the safety observation is a potential signal or not. Based on this, a signal is either validated or not validated
    • Signal analysis and prioritization – workflow to analyze and prioritize signals
    • Signal assessment – workflow to further evaluate validated signals to establish the causal relationship (rejected or confirmed signal) or to identify the need for additional data collection (undetermined signal). A customized report can also be generated to assess these signals.
    • Recommendations for action and communication – for confirmed signals
  • Generates comprehensive reports to ensure the entire process is managed appropriately – If findings are discovered, SigTrace has the data to identify the specific break in process.
  • Replaces the traditional mix of disparate processes, environments, databases and tools associated with signal management
  • All data is stored within SigTrace, eliminating the need for separate database or file storage repositories.

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ADDITIONAL RESOURCES

LitTrace and PVTrace

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Meet the Bioclinica Safety and Regulatory Team: Sukrit Singh, Engagement Manager

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