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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 biologit MLM-AI?

Biologit offers a wide array of software and services designed to enhance safety surveillance across various industries. At the forefront is their flagship product, biologit MLM-AI, a sophisticated medical literature monitoring system that leverages artificial intelligence for applications both globally and locally. This intuitive, web-based solution is validated for regulatory compliance, significantly boosting efficiency for human and veterinary pharmacovigilance efforts. Key features include integrated search functions and tailored literature screening methodologies, which can improve productivity by as much as 70% with the help of AI. Moreover, it boasts a versatile and validated SaaS framework that complies with GxP standards and adheres to CFR-11 regulations, along with a database that aggregates vital global and local literature while automatically eliminating duplicate articles. In addition to their software, Biologit extends its expertise through consultancy services focused on pharmacovigilance and veterinary pharmacovigilance, reinforcing their dedication to safety across multiple domains. Their continuous drive for innovation and adherence to compliance regulations firmly establishes them as a prominent figure in the industry landscape. This relentless commitment not only enhances their product offerings but also contributes to the overall advancement of safety practices in medical and veterinary fields.

Media

Media

Integrations Supported

XML
cubeCDMS
cubeCTMS

Integrations Supported

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

CRScube

Date Founded

2010

Company Location

South Korea

Company Website

www.crscube.io/solution/cubesafety

Company Facts

Organization Name

biologit

Date Founded

2021

Company Location

Ireland

Company Website

www.biologit.com

Categories and Features

Pharmacovigilance

Not specified

Categories and Features

AI Science

Not specified

Pharmacovigilance

Not specified

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