Audience
Life sciences organizations looking for a tool to enhance their safety signal detection and risk management processes
About DF mSignal AI
DF mSignal AI is a modular, scalable, and secure safety signal management system designed to enhance the efficiency of signal detection and risk management processes across pharmaceuticals, vaccines, medical devices, cosmetics, and nutraceuticals. The platform offers active and passive surveillance with real-time monitoring of product-event combinations, customizable clinical risk flags, and an interactive user interface with advanced analytics. It integrates seamlessly with MedDRA, WHO-DD, clinicaltrial.gov, and electronic data capture systems, providing a comprehensive solution for safety professionals. DF mSignal AI automates the computation of statistical scores, saving time and ensuring accuracy in signal detection and evaluation. The system is designed to meet all applicable regulations and guidance, such as 21 CFR Part 11, data integrity and privacy controls, and GxPs, ensuring compliance and security.
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Automated surveillance of any data source, fully integrated with a GVP IX compliant signal management platform. GVP-IX compliant signal management platform integrated within Evidex and ready to use off-the-shelf. Modernize and audit-proof your management processes without having to move back and forth between platforms and services. Unlock the value of your safety data. When you automate signal detection and management, you can focus not just on regulatory requirements, but on driving value for your organization. Identify safety signals from traditional sources like ICSR databases, FDA Adverse Event Reporting System (FAERS), VigiBase and clinical trial data. Include new data sources such as claims, EHR, and other unstructured data. Bring these pools of information together seamlessly to enhance signaling algorithms, make validations and assessment more efficient, and provide faster answers to drug safety questions.
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Company Information
Datafoundry
Founded: 2016
India
datafoundry.ai/m-signal/
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