Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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