Signal AI

DF Signal AI is a modular, scalable, and secure safety signal management system developed by Datafoundry. It is designed for use across pharmaceuticals, cosmetics, vaccines, nutraceuticals, food supplements, and medical devices. The system addresses the growing complexity of safety signal management by automating detection, evaluation, and reporting processes, drawing on data ingested from multiple regulatory agency portals and company safety databases.

Signal AI targets pharmacovigilance and drug safety teams that face increasing volumes of reported cases from diverse sources — including social media, call centers, literature, and real-world data — and need accurate, actionable outcomes without relying on heavily manual workflows. The platform operates on a product-event combination basis and provides statistical scores and analytics to support both active and passive surveillance.

Key Challenges Addressed

• High volumes of reported signals with insufficient actionable or accurate outcomes
• Manual, effort-intensive processes for signal detection and processing
• Increasing number of safety cases from new and varied data sources
• A dynamic and evolving regulatory landscape

Core Features

• Active and passive surveillance with real-time monitoring of product-event combinations
• Automated multimodal signal detection with composite signal scores
• Statistical scores automatically generated from ingested safety data
• Customizable clinical risk flags
• In-built quality control feature to approve or reject signal reports
• Customizable filters for reporting and audit trail
• Interactive user interface with advanced analytics
• Automated FMEA (Failure Mode and Effects Analysis) approach-based risk analysis for signal evaluation
• Generates signal schedules, signal notification forms, and signal reports
• Trends and analytics based on composite database disproportionality outcomes
• Regulatory intelligence feed available on the dashboard
• Multi-format data representations for collaborative risk monitoring
• Language pack configurations available, including Japanese and Chinese

Integrations and Compatibility

• Integrates with MedDRA and WHO-DD terminology standards
• Connects with ClinicalTrials.gov and EDC systems
• Compatible with Datafoundry's Safety AI platform
• Designed to integrate with other industry-leading safety databases and platforms
• Functions as a standalone module that can be incorporated into existing safety infrastructure

Compliance and Security

• Designed to meet 21 CFR Part 11 requirements
• Incorporates data integrity and privacy controls
• Aligned with GxP guidelines
• Delivered as a secure SaaS product

Signal AI is a cloud-based solution with a user interface developed with input from domain experts. It is positioned as an end-to-end signal management system and can be deployed as a standalone module or integrated with Datafoundry's broader suite of safety and pharmacovigilance tools.