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MeDRA Coding

GenAI-Powered ICSR Auto-Coding - Reducing Risk, Enhancing Speed in Adverse Event Management

Demo Of MeDRA coding

Pharmacovigilance teams rely on timely and accurate classification of adverse event data.

But when auto-coding systems can't keep up with free-text patient input, manual intervention becomes inevitable-and costly. GenAI offers a smarter path forward.

  • The Challenge: Manual Coding Gaps, Delays in Safety Case Processing

    A leading life sciences organization found its existing auto-coding tools falling short.

    The system struggled to:

    • Accurately interpret verbatim case descriptions
    • Map terms correctly to MedDRA codes
    • Process high volumes of ICSR data in a timely manner

    This resulted in increased reliance on manual reviewers, delayed recognition of serious safety signals, and greater compliance risk.

     

  • Why It Matters for Drug Safety Teams

    ICSRs are the foundation of pharmacovigilance-and speed and accuracy in coding them can be the difference between proactive intervention and reactive damage control.

    GenAI transforms ICSR workflows by:

    • Reducing Manual Burden: Automatically code MedDRA terms with high precision
    • Improving Consistency: Ensure uniformity in adverse event classification
    • Prioritizing High-Risk Cases: Spot critical safety signals early in the process
    • Accelerating Case Throughput: Speed up end-to-end safety processing

     

The Intelligent Shift: From Rule-Based Coding to Context-Aware Automation

  • Navikenz deployed a GenAI-powered solution that enhances ICSR auto-coding by understanding context, suggesting optimal MedDRA terms, and streamlining the user experience.

     

    What We Delivered:

    • Automated Code Identification: AI-powered system processes "Reported Terms" and maps them to appropriate MedDRA codes across hierarchical levels
    • Intelligent Recommendations: When uncertain, the system proposes the most relevant alternatives for review
    • User-Friendly Interface: A seamless UI to enter terms and instantly view matched MedDRA codes

     

  • The Results: Smarter Safety, Faster Action

    Outcome

    Impact

    Reduced Manual Intervention

    Significant drop in manual coding workload

    Improved Accuracy

    Higher precision in MedDRA term identification

    Case Prioritization

    Early flagging of serious cases during ICSR intake

    Faster Case Processing

    Shorter turnaround from report intake to safety action

    This isn't just about automation-it's about building a more resilient, responsive safety infrastructure.

     

A Call to Action

Modernize ICSR Management with GenAI

  • At Navikenz, we help drug safety teams reimagine their ICSR workflows using intelligent automation and GenAI-powered decision support. If your current system is still relying on outdated rules and high-touch review, we can help transform it into a scalable, smart-first operation.

     

    Safety data deserves speed-and you deserve smarter tools.
    Let's explore how GenAI can take your ICSR coding to the next level.