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Ratings and Reviews 0 Ratings
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Efficiently monitoring a variety of data sources, in conjunction with a GVP IX compliant signal management system, can significantly enhance the way safety data is processed. The Evidex platform provides a comprehensive, ready-to-use solution that adheres to GVP-IX standards, allowing for smoother operations without the need to navigate through multiple services. By updating your management workflows, you can create processes that are both efficient and resistant to audits. This level of automation aids in fulfilling regulatory requirements while simultaneously increasing the overall benefits for your organization. Through the use of automated signal detection, safety signals can be recognized from key resources, such as ICSR databases and the FDA's Adverse Event Reporting System (FAERS), alongside VigiBase and clinical trial information. Additionally, you can enhance your data landscape by adding other sources like claims, electronic health records (EHR), and various forms of unstructured data. By combining these different data sources, you can enhance signaling algorithms, streamline validation processes, and respond more swiftly to urgent drug safety issues. Furthermore, this innovative approach redefines how organizations handle and utilize safety data, ultimately leading to improved results and a more proactive stance on drug safety management.
What is DF mSignal AI?
DF mSignal serves as a flexible and scalable system for the management of safety signals, significantly improving the effectiveness of risk management and signal detection within the pharmaceutical and medical device sectors, while also encompassing areas such as cosmetics and nutraceuticals. The platform offers both active and passive monitoring, featuring real-time monitoring of product-event combinations along with customizable clinical risk indicators and a user-friendly interface enriched by advanced analytics. It effortlessly integrates with MedDRA, WHO DD, clinicaltrial.gov, and various electronic data collection systems, delivering a holistic safety solution for industry professionals. Additionally, DF mSignal AI employs automation to calculate statistical scores, streamlining the signal detection process and enhancing accuracy. The system is meticulously designed to adhere to all relevant regulations, including 21 CFR Part 11, and incorporates stringent data privacy and integrity controls, as well as Good Practice guidelines (GxPs), to guarantee compliance and security for users. With its comprehensive features, DF mSignal not only optimizes safety signal management but also fosters confidence among stakeholders in the regulatory landscape.
Integrations Supported
Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL
Integrations Supported
Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Advera Health Analytics
Date Founded
2010
Company Location
United States
Company Website
www.adverahealth.com
Company Facts
Organization Name
Datafoundry
Date Founded
2016
Company Location
India
Company Website
datafoundry.ai/m-signal/