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What is Veeva Vault Safety?

Veeva Vault Safety is a sophisticated system engineered for the oversight of individual case safety reports, streamlining the collection, management, and reporting of adverse events associated with both clinical studies and marketed products. This all-encompassing platform empowers sponsors and contract research organizations (CROs) to efficiently address both global and local adverse events across a range of categories, such as pharmaceuticals, biologics, vaccines, medical devices, and combination products. With its integrated gateway connections and established reporting protocols, the system significantly boosts the efficiency of case submissions to regulatory bodies and facilitates the sharing of pertinent information with various partners. Moreover, the centralized management of coding dictionaries ensures that updates for MedDRA, WHODrug, and EDQM occur semi-annually, thereby maintaining accuracy and compliance. By unifying pharmacovigilance processes within a single cloud-based environment, Vault Safety champions proactive initiatives aimed at enhancing patient safety. The inclusion of real-time reports and dashboards, along with enhanced collaborative features, further improves visibility and adherence to adverse event reporting standards. In conclusion, this groundbreaking solution not only redefines safety management practices within the pharmaceutical sector but also enables a more agile and comprehensive approach to addressing patient safety issues effectively. As a result, it helps organizations stay ahead of regulatory demands while prioritizing the well-being of patients.

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.

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

Veeva

Company Location

United States

Company Website

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

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/

Categories and Features

Categories and Features

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