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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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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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