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Description

DF mSignal is a modular and scalable safety signal management system that enhances the efficiency of signal detection processes and risk management across pharmaceuticals and medical devices. It also includes cosmetics and nutraceuticals. The platform provides active and passive monitoring with real-time monitoring product-event combination, customizable clinical risk indicators, and an interactive interface with advanced analytics. It integrates seamlessly into MedDRA, WHO DD, clinicaltrial.gov and electronic data collection systems, providing a comprehensive safety solution for professionals. DF mSignal AI automates statistical scores to save time and ensure accuracy in signal detection. The system is designed to comply with all applicable regulations, including 21 CFR Part 11, data privacy and integrity controls, as well as GxPs. This ensures compliance and security.

Description

Veeva Vault Safety is an advanced system designed for the management of individual case safety reports, facilitating the collection, processing, and reporting of adverse events related to both clinical trials and marketed products. This comprehensive platform allows sponsors and contract research organizations (CROs) to handle both global and local adverse events for various categories, including drugs, biologics, vaccines, devices, and combination products. Its integrated gateway connections and established reporting protocols enhance the efficiency of submitting cases to regulatory authorities and sharing information with partners. Additionally, the centralized management of coding dictionaries automates updates for MedDRA, WHODrug, and EDQM on a semi-annual basis. By consolidating pharmacovigilance processes within a single cloud environment, Vault Safety promotes proactive measures in ensuring patient safety. The system also utilizes real-time reports and dashboards, coupled with seamless collaboration, to enhance visibility and ensure compliance regarding adverse event reporting. Ultimately, this innovative solution transforms the approach to safety management in the pharmaceutical industry, fostering a more efficient and effective response to patient safety concerns.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Datafoundry

Founded

2016

Country

India

Website

datafoundry.ai/m-signal/

Vendor Details

Company Name

Veeva

Country

United States

Website

www.veeva.com/products/vault-safety/

Product Features

Product Features

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