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What is cubeCTMS?

cubeCTMS serves as a comprehensive clinical trial management platform that ensures thorough supervision of trials, which includes monitoring study sites and investigators, handling participant enrollment and visit schedules, and managing budgets and contract workflows, along with milestone reporting and document oversight. By consolidating study operations and automating key processes, it enables sponsors, CROs, and research teams to track progress in real time, coordinate activities across multiple studies, improve communication with study sites, and mitigate risks. The platform features integrated dashboards, alerts, and audit-ready documentation to maintain compliance with regulatory requirements, including readiness for FDA 21 CFR Part 11, thus empowering stakeholders to manage trial schedules, resources, and overall performance from a unified interface. Furthermore, cubeCTMS effortlessly integrates with other modules of CRScube, such as EDC, eTMF, and pharmacy/RTSM, forming a harmonious ecosystem that reduces redundancy, enhances data flow, and accommodates flexible workflows during amendments or extensive implementations. This integration not only streamlines various processes but also significantly boosts the overall effectiveness of clinical trials, ultimately proving to be an essential asset for research teams dedicated to advancing medical knowledge. With its user-friendly design and robust features, cubeCTMS sets a new standard in clinical trial management solutions.

What is RegDocs365?

A comprehensive, adaptable, and real-time collaborative solution designed for Clinical Research Organizations, Life Science Advisors, and other industry participants is available seamlessly. This system is constructed within an Audit Ready Compliant Cloud (ARCC) environment, ensuring compliance with all 21 CFR Part 11 standards and GxP audit readiness. It features pre-configured departmental setups that facilitate communication with both internal and external stakeholders, enabling secure data integration for remote teams. The platform supports collaborative review and approval processes, allowing access to be toggled based on necessity (such as during audits), which significantly decreases audit preparation time from several days to mere hours. Additionally, it comes ready to align with eTMF Reference models and EDM, while intelligent content management capabilities enhance workflow efficiency. With real-time collaboration, automatic indexing, and co-authoring functionalities, document management becomes more streamlined. This validated system is specifically designed to handle documents and data electronically, adhering to eCTD regulations, thereby ensuring that all stakeholders can operate effectively and efficiently. By embracing this technology, organizations can transform the way they manage and share vital documents in the life sciences sector.

Media

Media

Integrations Supported

cubeCDMS
cubeSAFETY

Integrations Supported

Crow Canyon Contract Management

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Per user, Per month

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

CRScube

Date Founded

2010

Company Location

South Korea

Company Website

www.crscube.io/solution/cubectms

Company Facts

Organization Name

Court Square Group

Date Founded

1995

Company Location

United States

Company Website

www.regdocs365.com

Categories and Features

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
HIPAA Compliant

Document Control

Not specified

Document Management

Not specified

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