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What is cubeSAFETY?

cubeSAFETY is a cutting-edge pharmacovigilance solution that aids safety teams in the effective management of adverse event reporting, regulatory submissions, and case processing while ensuring compliance. It complies with ICH E2B as well as various regional reporting guidelines, enabling submissions to regulatory bodies such as the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, and it can automatically convert and format data for CIOMS and XML exports. The platform features AI-enhanced medical coding recommendations, duplication detection, the ability to import CIOMS PDF files, and dynamic dashboards for tracking submissions in real-time. Furthermore, it provides seamless integration with other CRScube modules, including cubeCDMS. Designed to improve the safety case entry process, cubeSAFETY ensures exceptional data quality through built-in validation tools and streamlines workflows to meet global regulatory standards, all while reducing manual efforts and costs. In essence, this innovative platform aspires to transform the landscape of pharmacovigilance by enhancing both efficiency and accuracy in the industry, making it a valuable asset for safety teams worldwide.

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

XML
cubeCDMS
cubeCTMS

Integrations Supported

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
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

CRScube

Date Founded

2010

Company Location

South Korea

Company Website

www.crscube.io/solution/cubesafety

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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