Best Safety Signal Management - DF mSignal AI

Key challenges in Safety Signal Management

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.

AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI

Increase in the volumes of reported signals

AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI

Large number of signals but not enough actionable, accurate outcomes.

AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI

Manual effort intensive process for signal detection and processing

AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI

Dynamic regulatory landscape

Automated Safety Signal Management - DF mSignal AI 

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.

Smart Electronic Medical Records and Patient Reported Outcomes Systems | RWD based Clinical Trials | Digital Trials

Features of  DF mSignal AI 

A modern cloud-based signal management system, that delivers efficiencies, accuracy and early risk detection 

AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Active and passive surveillance with real time monitoring of Product-Event Combinations
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Customizable clinical risk flags
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
In-built QC feature to approved/reject a signal report
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Customizable filters for reporting & audit trial
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Interactive user interface & advanced analytics
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Integrates with MedDRA and WHO-DD, clinicaltrial.gov, EDC
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Automated FMEA approach-based risk analysis for signal evaluation
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Generates signal schedule, signal notification forms and signal reports
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Provides trends/analytics based on composite database disproportionality outcome
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Regulatory intelligence feed on the dashboard
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Language pack configurations available for Japanese, Chinese and more
AI augmented Safety Vigilance for Drugs, Cosmetics & Medical Devices | Transforming Pharmacovigilance and Drug Safety with AI
Easy to integrate with industry leading safety platforms
End-to-end Signal Management solution with a user-friendly interface for easy navigation and analytics.
Improve the efficiency of Signal Management process by
5X
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Improved Productivity and Accuracy

Automated multimodal signal detection composite signal scores.

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Modular Signal and Risk Management

Standalone module that can be integrated with any industry leading safety database.

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Secure and Compliant SaaS product

Designed to meet all applicable regulations and guidance such as 21 CFR Part 11, Data Integrity and Privacy controls, and GxPs.

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User Experience

Intuitive UI designed with inputs from domain experts to make signal management more efficient.

Resources

Get in touch and learn how DF mSignal AI can help you monitor and manage safety signals better.