Are you efficiently delivering compliant and effective Signal Management?

  • Signal management accounts for 26% of critical MHRA findings, second only to Reference Safety Information (28%)
  • Navitas Life Sciences research shows that nearly 50% of companies surveyed do not have a formal system in place for signal tracking
  • An optimized and compliant signal management system using a strategic approach enabled by technology and cross-functional governance to identify, assess and track signals

Key Issues Addressed

  • Incomplete monitoring of all required sources of potential signals
  • Inefficient processes / tools for detecting, prioritizing, evaluating, or tracking signals
  • Recent inspection & audit findings in signal management
  • Non-compliance with revised EU GVP Module IX

Navitas Life Sciences Provides an Integrated Approach Leading to Impactful Results

  • Assessment and redesign of signal management processes and tools
  • Gap analysis of signal management processes and governance compared to best practice benchmarks and new regulatory requirements like EVDAS
  • Implementation of refined signal management processes, tools, and governance
  • Sourcing and project management of the implementation of signal management technology

Deliverables

  • A strategic approach to signal management from signal to patient that is enabled by fit-for-purpose technology and cross-functional governance
  • Strategies for detection and timelines for each step from identification / detection through to decision and recommendation for action
  • A tiered approach to signal detection based on structured product portfolio prioritization to deliver compliant and efficient signal management
  • SOPs, work instructions, templates and job aids to support end - to - end the signal management process from
  • Simplified oversight through the identification and implementation of fit - for - purpose technology to produce on-demand reports

Benefits

  • A compliant and efficient signal management process
  • A signal management system based on a strategic approach to signal identification, assessment and tracking that is enabled through technology and governance
  • Identification and implementation of appropriate technology to manage and track signals

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