Signal Management

Signal Detection is a complex area within pharmacovigilance services which requires a high level of professional work.

Signal management can be deployed throughout both the clinical development and postmarketing phases of the product lifecycle.

Signal detection in Pharmacovigilance involves looking at the adverse reaction data for patterns that suggest new safety information.

The process for managing signals within pharmaceutical companies and regulatory authorities / pharmacovigilance centres must systematically address the following steps:

  • Signal detection
  • Validation and Confirmation
  • Analysis
  • Prioritisation
  • Assessment
  • Recommending action

All steps taken and recommendations made must be accurately tracked and documented at every stage.

Please note that signal management in Pharmacovigilance is a complex area within pharmacovigilance. We do this using a wide range of sources, e.g., spontaneous cases, safety data from clinical trials, and non-interventional studies and literature reports.

For further information, please contact us.

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