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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 PvEdge?

PvEdge represents a cutting-edge cloud-based software solution specifically designed for pharmacovigilance, offering thorough and compliant safety measures for pharmaceuticals, medical devices, vaccines, and their combinations. This innovative platform integrates a comprehensive safety database that simplifies the management of pharmacovigilance intake, case processing, submissions, AI-enhanced analytics, and safety signal detection, all within an intuitive interface. It is meticulously crafted to comply with both current and future regulatory requirements, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring adherence to global standards. By leveraging advanced automation powered by AI and machine learning, PvEdge greatly enhances the efficiency of managing drug safety databases. Key features include automated literature reviews, rapid ICSR submissions, intelligent triage processes, automated signal detection, and efficient document automation. Moreover, the platform incorporates a controlled document management system that aids in the creation, management, and distribution of vital pharmacovigilance documentation, coupled with a risk-based enterprise quality management framework that promotes strong quality control practices and keeps detailed training records. Overall, these multifaceted capabilities position PvEdge as an essential asset for organizations dedicated to maintaining exemplary standards in drug safety while adapting to the evolving landscape of regulatory demands. As a result, it empowers businesses to operate more effectively and responsibly in their commitment to patient safety.

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

PvEdge

Date Founded

1998

Company Location

India

Company Website

pvedge.sarjen.com

Categories and Features

Categories and Features

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