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Description
cubeCDMS is a comprehensive electronic data capture solution specifically crafted for the management of clinical trial operations, enhancing the entire data collection and oversight process. This advanced system encompasses complete data management workflows, featuring automatic detection of protocol violations, batch management of queries, and integrated risk-based monitoring that collectively contribute to heightened data integrity and operational effectiveness. With its user-friendly, no-code interface, study teams can effortlessly create electronic case report forms (eCRFs) from a library boasting over 55 pre-designed forms and edit checks, enabling swift database setups and minimizing start-up times. Tailored for ease of use, cubeCDMS facilitates single data entry that is automatically shared across various integrated CRScube modules, thereby decreasing redundancy and simplifying the reconciliation process. Moreover, it offers a range of additional advantages, such as AI-enhanced medical coding assistance, intuitive drag-and-drop form creation tools, support for multiple languages, and comprehensive audit trails along with tracking of change histories, ensuring transparency and reliability throughout the trial process. This innovative solution empowers clinical researchers to focus more on their studies while optimizing their data management practices.
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
API Access
Has API
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
CRScube
Founded
2010
Country
South Korea
Website
www.crscube.io/solution/cubecdms
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
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management