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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 NewTn-SAFETY?

NewTn's SAFETY is an innovative cloud-based platform designed for pharmacovigilance, focused on simplifying safety processes and ensuring compliance for pharmaceutical enterprises, emerging startups, and contract research organizations. This advanced solution offers a diverse range of features, including a scalable cloud infrastructure that enhances data storage and processing capabilities, the functionality to reuse data to minimize redundant entries, and real-time alerts and monitoring systems for the prompt identification of adverse reactions. Additionally, it provides robust reporting tools that facilitate the creation of essential documents such as DSUR and PBRER reports. Various practical applications underscore its importance in developing safety databases for new pharmaceutical companies, delivering cost-effective safety solutions for budget-minded CROs, enhancing regulatory compliance for small and mid-sized pharmaceutical entities, and offering comprehensive analysis and reporting of safety data. The platform stands out due to its intuitive user interface and experience, along with tailored support specifically for DSUR and PBRER reporting, making it a flexible and personalized option for different participants in the pharmaceutical sector. Furthermore, NewTn's SAFETY empowers all users to adeptly navigate the complexities associated with safety management, ensuring they do so with both confidence and ease, ultimately contributing to improved patient safety outcomes.

Media

Media

Integrations Supported

XML
cubeCDMS
cubeCTMS

Integrations Supported

XML
cubeCDMS
cubeCTMS

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

CRScube

Date Founded

2010

Company Location

South Korea

Company Website

www.crscube.io/solution/cubesafety

Company Facts

Organization Name

NewTn-SAFETY

Company Location

United States

Company Website

safety.newtn.life/

Categories and Features

Categories and Features

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