Modernizing ICSR Management

The Modernizing ICSR Management initiative seeks to galvanize the ecosystem to reimagine the Individual Case Safety Report (ICSR) management and sharing paradigm by designing and piloting a new way of working to ultimately serve patients better.

Key resources

Rationale

The current practice of managing and sharing ICSRs across the ecosystem, established in the 1960s, has become inefficient, burdened with ICSR duplication and replication, and results in a fragmented understanding of product safety profiles. Evolving safety regulations and increasing case volumes call for a new path forward that is sustainable and enhances public health.

This initiative aims to embark on that path with a conceptual ICSR management model that could mitigate duplication and replication, allow ecosystem stakeholders to access the latest source of truth on demand, facilitate more meaningful safety analysis and interpretation, and ultimately enable a real-time learning healthcare system to improve patient safety and health outcomes.

The Modernizing ICSR Management initiative is focused on four initial components to capture the breadth of the current state problem and demonstrate the feasibility and potential value of a new operating model.

Benefits

The primary benefit of initial solutions is to foster conversations between stakeholders with reasons and ideas to change the current state of ICSR management and safety data sharing. Through these efforts, the vision of a modernized future state will be explored with the following expected benefits:

  • Reduced Burden and Improved Access
    • Efficiencies in sponsor operations to meet regulatory requirements
    • Enhanced global connectivity and decision-making for all stakeholders
  • Refocused Effort on Higher-Value Activities
    • Enabling a real-time learning healthcare system
    • Optimization of PV resources to refocus effort on higher-value benefit-risk activities
  • Enhanced Patient Safety and Trust
    • Reduced risk of delayed or inaccurate safety analysis for patients
    • Earlier public release for critical safety profile information