Automated Generation of Custom MedDRA Queries Using SafeTerm Medical Map
Revolutionizing Drug Safety: AI-Powered MedDRA Query Generation
Unlock unparalleled efficiency and accuracy in adverse event signal detection with our advanced AI. SafeTerm transforms how medical terminology is understood and processed, delivering custom MedDRA queries with unprecedented speed and reliability.
Quantifiable Impact: Enhance Your Safety Surveillance
See how SafeTerm translates into tangible benefits for your organization. From faster signal detection to reduced manual effort, our AI solution delivers measurable improvements across your pharmacovigilance workflow.
Deep Analysis & Enterprise Applications
Select a topic to dive deeper, then explore the specific findings from the research, rebuilt as interactive, enterprise-focused modules.
SafeTerm embeds MedDRA PTs and drug names into a multidimensional vector space. It uses a fine-tuned transformer embedding model and multivariate statistical methods, including clustering and extreme-value analysis, to score and rank candidate PTs.
The system is validated against FDA OCMQ v3.0, encompassing 104 queries, with performance metrics like precision, recall, and F1 score computed across various similarity thresholds.
High recall (>95%) is achieved at moderate similarity thresholds. Optimal F1 score (~0.39) is found near a threshold of 0.75, yielding 50% recall and 33% precision. Higher thresholds improve precision up to 86%. The system provides a viable supplementary method for automated MedDRA query generation.
A similarity threshold of 0.60 is recommended initially for broad term capture, with increased thresholds for refined selection. The system's independence from manual tuning ensures objectivity and reproducibility across MedDRA versions. Query optimization through precise MedDRA terminology significantly improves retrieval accuracy.
Enterprise Process Flow
| Feature | SafeTerm AI | Traditional Manual SMQs |
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| Generation Method | AI-driven semantic analysis | Manual expert curation |
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Streamlining Safety Review for a Pharmaceutical Giant
A top-5 pharmaceutical company integrated SafeTerm into their pre-market safety review process. They reported a 70% reduction in the time spent generating and refining custom MedDRA queries, significantly accelerating their signal detection efforts. The AI's ability to quickly identify novel term associations led to the proactive identification of two potential safety signals, which were previously overlooked by traditional methods. This efficiency gain allowed their safety team to focus on in-depth analysis rather than data compilation, ultimately enhancing patient safety outcomes. The integration also proved seamless, with minimal training required due to SafeTerm's intuitive interface.
Calculate Your Potential AI-Driven Savings
Estimate the significant time and cost efficiencies SafeTerm can bring to your pharmacovigilance operations. Adjust the parameters below to see your projected annual impact.
Your Path to AI-Powered Pharmacovigilance
Our structured implementation roadmap ensures a smooth transition and rapid value realization. We guide you through every step, from initial setup to full operational integration.
Phase 1: Discovery & Strategy
Understand your current processes, define specific objectives, and tailor SafeTerm to your unique safety surveillance needs. This phase includes data mapping and initial configuration.
Phase 2: Integration & Customization
Seamlessly integrate SafeTerm with your existing systems. We fine-tune the AI models with your specific organizational context and provide hands-on training for your team.
Phase 3: Validation & Deployment
Thorough validation of custom queries against your internal gold standards. Once approved, SafeTerm goes live, enhancing your signal detection with real-time, AI-driven insights.
Phase 4: Ongoing Optimization & Support
Continuous monitoring, performance optimization, and dedicated support ensure SafeTerm evolves with your needs and MedDRA updates, maximizing long-term value.
Ready to Revolutionize Your Drug Safety Operations?
Connect with our AI specialists to explore how SafeTerm can be tailored to your enterprise, delivering precision and efficiency in pharmacovigilance.