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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

cubeCTMS is an all-encompassing clinical-trial management platform that facilitates complete oversight of trials, encompassing aspects such as tracking study sites and investigators, managing enrollment and visit schedules, and overseeing budget and contract workflows, as well as milestone reporting and document management. By centralizing study operations and automating essential processes, it allows sponsors, CROs, and study teams to oversee progress in real time, coordinate tasks across various studies, enhance communication with sites, and reduce risks. The platform offers integrated dashboards, notifications, and audit-ready documentation to ensure compliance with regulatory standards, including readiness for FDA 21 CFR Part 11, empowering stakeholders to oversee trial timelines, resources, and overall performance from a singular interface. Additionally, cubeCTMS seamlessly connects with other CRScube modules, such as EDC, eTMF, and pharmacy/RTSM, creating a cohesive ecosystem that minimizes redundancy, optimizes data flow, and supports flexible workflows during amendments or large-scale implementations. This integration not only streamlines processes but also enhances the overall efficiency of clinical trials, making it an invaluable tool for research teams.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

cubeCDMS Yes 
XML No 
cubeCTMS No 
cubeSAFETY Yes 

Integrations

cubeCDMS Yes 
XML Yes 
cubeCTMS Yes 
cubeSAFETY 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 No 
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 Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

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

Types of Training

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

Vendor Details

Company Name

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubectms

Vendor Details

Company Name

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubesafety

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

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