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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 K2C PSMF Solution?

The K2C PSMF Solution introduces a groundbreaking approach to managing the Pharmacovigilance System Master File. It is crucial to periodically revise this document whenever significant changes occur in the pharmacovigilance protocols. These changes require input from multiple roles within the organization to modify a cohesive document that is structured according to regulatory guidelines. However, the process of coordinating these edits can be quite difficult, particularly because certain sections must be limited to designated editors and kept hidden from other contributors. To tackle this issue, the K2C solution treats each paragraph and annex as individual documents, making it easier to compile the final PSMF document by combining these various components. Furthermore, the K2C PSMF Solution manages contributions to the PSMF as separate entities, allowing for the control of access rights for both viewing and editing, while also providing thorough oversight of the entire document lifecycle, thereby ensuring compliance and efficiency throughout the entire process. This organized method not only improves collaboration among teams but also reinforces adherence to regulatory standards, ultimately enhancing the overall quality of the pharmacovigilance practices within the organization. As a result, the K2C PSMF Solution is an essential tool for organizations aiming to streamline their pharmacovigilance efforts.

Media

Media

Integrations Supported

Microsoft SharePoint

Integrations Supported

Microsoft SharePoint

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

€8,500 one-time payment
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

K2C

Company Location

United Kingdom

Company Website

www.k2c.com/products/K2Pharma/PSMF.html

Categories and Features

Categories and Features

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