Signal Management has always been a time-consuming manual process.
Increase in the number of safety cases and new sources (social media, call centers, literature, real world data) has made the process complicated and overwhelming.
Increase in the volumes of reported signals
Large number of signals but not enough actionable, accurate outcomes.
Manual effort intensive process for signal detection and processing
Dynamic regulatory landscape
DF mSignal AI is a powerful signal management system for drug, cosmetics, vaccines, nutraceuticals,food supplement and medical devices, that offers advanced, accurate and comprehensive coverage of signal detection and risk management. Based on product-event combinations, DF mSignal AI provides a powerful set of analytics and insights that enable active and passive surveillance of signals. Statistical scores are automatically generated from safety data ingested from multiple regulatory agency portals and company safety database/s. Multi-format data representations enable users to monitor potential risks and generate signal reports collaboratively.
DF mSignal AI is a modular, scalable and secure signal management system that can be integrated with
DF mSafety AI and other leading safety databases.
Automated multimodal signal detection composite signal scores.
Standalone module that can be integrated with any industry leading safety database.
Designed to meet all applicable regulations and guidance such as 21 CFR Part 11, Data Integrity and Privacy controls, and GxPs.
Intuitive UI designed with inputs from domain experts to make signal management more efficient.