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Signals Module


About the module

  • Maintain overview of observations and signals and track all the decisions and accumulated data over time, version controlled, audit logged and according to GVP Module IX.

  • Manage signal detection schedules and create Signal Detection Plans

  • Built-in quantative signal detection algorithms / views, to analyze drug-event combinations (DECs) over time and annotate cases. Go directly to ICSRs of interest for further analysis. Or can integrate with 3rd party detection tools, e.g. Commonwealth Vigilance Workbench or BI

  • Ability to pull in multiple datasets, including "internal data" from Safety Database (see ICSRs module), OpenFDA, EVDAS - other options can be setup.

  • Auto-generate Signal reports or Signal Management Review reports, format using Word templates. Template based document creation but also with “Snippets that allow controlled introduction of non-core template text

  • Link to Risks, promote a confirmed signal to a risk/safety concern or setup a routine detection activity from a risk management activity

  • Link to Requirements Intelligence to ensure that signal notifications are handled timely

  • Maintains an audit trail for all changes and updates

  • Is GxP validated* and ready to use in the cloud


Viewing signal detection data over time is easy with HALOPV. Go back in time and investigate case listings from any "slice" of data that you have generated. You can set your periodicity for each Safety Topic and also define many parameters for the data set to be generated, across multiple sources

*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.

Want to know more, get a demo or take it for a test drive?

We would love to tell you more and answer any questions you have, take you through a demo or let you test the system so you can explore yourself. Just email


We look forward to working with you.

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