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features
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Description

cubeSAFETY is an advanced pharmacovigilance platform designed to assist safety teams in efficiently managing adverse-event reporting, regulatory submissions, and case processing in a compliant manner. It adheres to ICH E2B and various regional reporting standards, facilitating submissions to agencies like the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, while also automatically converting and formatting data for CIOMS and XML export. The platform boasts AI-driven medical coding suggestions, duplication detection, the capability to import CIOMS PDF files, and dynamic dashboards for real-time submission tracking. Additionally, it offers complete integration with other CRScube modules, including cubeCDMS. cubeSAFETY is crafted to enhance the safety-case entry process, guarantee superior data quality through embedded validation features, and streamline workflows for compliance with global regulatory requirements, all while decreasing manual labor and financial overhead. Ultimately, this innovative platform aims to redefine pharmacovigilance efficiency and accuracy across the industry.

Description

eProtocol serves as a comprehensive online platform dedicated to research compliance for various institutions overseeing human subjects, animals, biosafety, and other regulated studies. This system facilitates the development and electronic submission of protocols, as well as the workflows for committee review and approval, amendments, renewals, reporting of adverse events, automated routing and reminders, version control, meeting agendas and minutes, audit trails, and comprehensive reporting. Users such as investigators, coordinators, reviewers, and compliance administrators can efficiently monitor protocol statuses and access relevant records through a collaborative interface. The platform features specific modules tailored for IRB, IACUC, IBC, stem-cell research, chemical safety, radiation safety, controlled substances, and post-approval monitoring processes. eProtocol is specifically crafted to meet the needs of universities, research institutions, hospitals, academic medical centers, biotech and pharmaceutical companies, as well as governmental research agencies, ensuring a streamlined approach to compliance across diverse research environments. Additionally, it enhances the overall efficiency of regulatory processes, ultimately contributing to the integrity and safety of research activities.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

XML Yes 
cubeCDMS Yes 
cubeCTMS Yes 

Integrations

XML No 
cubeCDMS No 
cubeCTMS No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubesafety

Vendor Details

Company Name

Key Solutions

Founded

1991

Country

United States

Website

www.keyusa.com

Product Features

Product Features

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