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What is Oracle Life Sciences Empirica?

Oracle Life Sciences Empirica is recognized as the leading tool for detecting, analyzing, and managing safety signals associated with drugs, biologics, vaccines, devices, and combination products in both pre-market and post-market scenarios. Oracle dedicates significant resources to research and development, continually refining the advanced data-mining algorithms and statistical techniques that underpin Empirica. This forward-thinking strategy enables the early detection of signals, providing risk insights up to 22 months ahead of conventional labeling revision schedules based on time-indexed benchmarks. Safety teams involved in signal management face growing challenges, including the discovery of hidden signals, analyzing vast datasets, and enhancing the safety information available prior to clinical trials. To delve deeper into how cutting-edge methodologies and technologies, including artificial intelligence, can address these pressing issues, we invite you to read our ebook, which offers essential insights and actionable solutions. By leveraging these resources, organizations can better navigate the complexities of safety signal management in a rapidly evolving landscape.

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.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

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

Oracle

Date Founded

1977

Company Location

United States

Company Website

www.oracle.com/life-sciences/safety-solutions/empirica-safety-signal-management/

Company Facts

Organization Name

Datafoundry

Date Founded

2016

Company Location

India

Company Website

datafoundry.ai/m-signal/

Categories and Features

Categories and Features

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