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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 OpenSourcePV?

Founded by Lionel Van Holle in 2019, OpenSourcePV is dedicated to utilizing open-source technologies to improve standards in pharmacovigilance and provide a budget-friendly alternative to expensive specialized software. As pharmaceutical companies are obligated to ensure the safety of their products to comply with regulations, the increasing complexity of their product lines leads to an overwhelming amount of data that manual analysis struggles to manage. Currently, they are caught between the choice of investing in costly software solutions or attempting to create an internal system from scratch. OpenSourcePV aids these organizations on their path to effective quantitative signal detection by offering pre-built modules that can also be customized to meet specific needs and integrate with diverse data sources. This adaptability not only streamlines the management of extensive datasets but also enhances the overall efficiency of their pharmacovigilance efforts, paving the way for safer pharmaceuticals. As the industry evolves, the role of OpenSourcePV becomes increasingly crucial in supporting these companies to navigate their challenges.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Free
Free Version

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

Veeva

Company Location

United States

Company Website

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

Company Facts

Organization Name

OpenSourcePV

Date Founded

2019

Company Location

United States

Company Website

www.opensourcepv.com

Categories and Features

Pharmacovigilance

Not specified

Categories and Features

Pharmacovigilance

Not specified

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