DF mSafety AI is a comprehensive, cloud-based safety platform that leverages artificial intelligence (AI) and machine learning (ML) to streamline and optimize safety case management and signal detection processes. It is specifically designed to address the complex challenges faced by safety departments in the pharmaceutical, cosmetics, vaccine, nutraceutical, and medical device industries, including the increasing volume of adverse event reports from diverse sources like social media, call centers, and real-world data. Built on Datafoundry’s Integrated Cloud Platform - DF Safety 4.0, DF mSafety AI ensures scalable and secure AI/ML-driven safety case and signal management. It features pre-built connectors for seamless integration with existing enterprise systems and adheres strictly to global regulatory requirements and industry standards. Developed by industry experts in collaboration with world-class data scientists and ML pioneers, the platform provides an end-to-end solution for safety management, from initial case intake and triage through medical review and final regulatory submission. The platform aims to deliver significant efficiencies and an improved user experience by automating critical tasks, thereby reducing manual effort, improving data accuracy, and accelerating compliance. Key components of DF mSafety AI, such as AI-powered Case Intake, Signal Detection, and Literature Monitoring, are also available as standalone products, offering flexible integration with customers’ existing safety databases.

Features & Benefits

• AI-Powered Case Intake & Triage
  • Automates the collection and initial processing of safety cases from multiple disparate sources, including unstructured data, and performs intelligent triage.
• Signal Detection & Risk Management
  • Provides advanced tools for accurate and comprehensive coverage of signal detection and management, enabling proactive risk mitigation.
• Literature Monitoring for Safety
  • Automates the review and extraction of relevant safety information from scientific literature.
• Comprehensive Automation Features
  • Integrates a suite of AI/ML-powered automation capabilities for end-to-end pharmacovigilance.
  • Multi-Source Case Intake Options
  • Automated Triage Rule Configuration
  • Seriousness Prediction
  • Causality Assessment
  • Expectedness and Listedness Assessment
  • Auto Narrative Generation
  • Custom Report Generation
  • Literature Monitor for Safety
  • Signal & Risk Management
  • Case Compliance Alerts
  • Integrated MedDRA and WHO-DD Browsers
  • Enhanced E2B R2 & R3 Compliance
  • E-Submissions Gateway
• Reduced Manual Effort & Improved Productivity
  • Significantly cuts down manual effort by up to 70%, leading to improved productivity and reduced time to screen and triage cases.
• Increased Accuracy
  • Achieves very high accuracy in the extraction of information and medical facts from documents and images in multiple formats.
• Faster ROI & Easy Integration
  • Compliments existing safety databases and case management systems through easy integration using industry standards, accelerating return on investment.