DF mSignal AIDatafoundry
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Related Products
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About
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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About
Quanticate offers comprehensive pharmacovigilance services, including the provision and management of pharmacovigilance safety databases. A pharmacovigilance safety database serves as the central repository for individual case safety reports collected globally for a company's medicinal products. It is essential that these databases are up-to-date with the latest regulatory requirements and validated to meet international standards and business needs. Quanticate emphasizes the importance of selecting the right database by considering factors such as implementation and maintenance costs, hosting model availability (internal infrastructure, third-party hosting, or vendor cloud options), prior experiences, and compatibility with other systems. They caution that while many commercially available databases claim compliance with standards like ISO ICSR ICH-E2B, true compliance requires careful setup, validation, and management.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Life sciences organizations looking for a tool to enhance their safety signal detection and risk management processes
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Audience
Pharmaceutical companies and clinical research organizations needing a solution for managing safety data across the lifecycle of their medicinal products
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationDatafoundry
Founded: 2016
India
datafoundry.ai/m-signal/
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Company InformationQuanticate
Founded: 1994
United Kingdom
www.quanticate.com/pharmacovigilance-safety-database
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Categories |
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Integrations
No info available.
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Integrations
No info available.
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