DF Safety AI

DF Safety AI is a cloud-based safety management platform developed by Datafoundry that applies AI/ML and automation to pharmacovigilance workflows covering drugs, cosmetics, vaccines, nutraceuticals, and medical devices. It is built on Datafoundry's integrated cloud platform, DF Safety 4.0, and is designed for safety departments in life sciences organisations that need to manage growing volumes of adverse event cases from multiple sources while meeting regulatory requirements.

The platform addresses common challenges in safety case management, including inaccuracies during case intake, increasing case volumes from emerging markets, manual extraction of safety information from varied formats and sources (such as social media, call centres, literature, and real-world data), and the high cost of intake, deduplication, and triage operations. DF Safety AI covers the full case lifecycle from intake and triage through medical review and regulatory submission.

Core Capabilities

• AI-powered case intake from multiple sources, including documents and images in multiple formats
• Automated triage rule configuration
• Seriousness prediction using ML models
• Causality assessment
• Expectedness and listedness assessment
• Auto narrative generation for safety cases
• Custom report generation
• Literature monitoring for safety signals
• Signal detection and risk management
• Case compliance alerts
• Integrated MedDRA and WHO-DD browsers
• Enhanced E2B R2 and R3 compliance support
• E-submissions gateway for regulatory reporting

Standalone Components

The following key components of DF Safety AI are also available as standalone products that can be integrated with customers' existing safety databases:

• AI-powered case intake from multiple sources and case triage
• Signal detection and risk management
• Literature monitoring for safety

Reported Performance Outcomes

• Reduction in manual effort by up to 70%
• Reduced time to screen and triage cases, supporting improved productivity
• High accuracy in extracting information and medical facts from documents and images across multiple formats
• Faster return on investment through integration with existing safety databases and case management systems using industry standards

AI Data and Analytics Services

• AI data labelling and ML model validation
• ML model as a service
• Data as a service
• Analytics as a service

DF Safety AI is deployed as a cloud-based platform and supports pre-built connectors to enterprise systems. It is designed to adhere to regulatory requirements and industry standards, including E2B R2 and R3 formats. The platform can function as an end-to-end pharmacovigilance solution or complement existing safety databases through its standalone module options.