Three Integrated Modules
Data Intelligence
Ingest, harmonize, and analyze safety and efficacy data from all sources in a single unified platform.
  • Multi-source data integration (clinical trials, FAERS, EHR, claims, literature)
  • AI-powered safety signal detection with 73% faster identification
  • Real-world evidence analytics with automated study execution
  • NLP-driven case narrative processing and MedDRA coding
  • Continuous literature and regulatory intelligence monitoring
Decision Intelligence
Build quantitative benefit-risk models using MCDA methodology enhanced by machine learning.
  • Multi-criteria decision analysis (MCDA) with BRAT Framework support
  • Probabilistic sensitivity analysis (Monte Carlo simulation)
  • Dynamic preference modeling for multiple stakeholder groups
  • Interactive visualizations (tornado, spider, value trees)
  • Living BRA models with automatic data-driven updates
Automated Outputs
Generate regulatory-ready documents and reports with AI-assisted narrative writing and formatting.
  • Automated PBRER/PSUR generation (ICH E2C(R2) compliant)
  • Regulatory submission-ready BRA sections for CTD Module 2.5
  • HTA dossier preparation with multi-country adaptation
  • Signal evaluation reports and risk management plans
  • Advisory committee presentation materials
Key Metrics
73%
Faster signal
detection
60%
Reduction in BRA
preparation time
75%
Faster PBRER
generation
89%
Reduction in
false positives
Key Capabilities
  • Quantitative benefit-risk assessment (MCDA/BRAT)
  • AI safety signal detection and prioritization
  • Real-world evidence integration and analytics
  • Automated PBRER/PSUR document generation
  • Network meta-analysis and indirect comparisons
  • Cost-effectiveness and budget impact modeling
  • Patient preference integration (DCE support)
  • Multi-stakeholder scenario analysis
  • Regulatory intelligence and horizon scanning
  • Full audit trail with 21 CFR Part 11 support
Integrations
Argus Safety ArisG FAERS EudraVigilance VigiBase Medidata Rave Veeva Vault OMOP CDM Sentinel CDM Flatiron Health Optum EHR CPRD PubMed/Embase ClinicalTrials.gov
Security & Compliance
SOC 2 Type II
HIPAA
GDPR
GxP Ready
21 CFR Part 11
ISO 27001
EU AI Act