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What is eTMF Connect?

We are excited to unveil the newest iteration of eTMF Connect, a solution crafted with a focus on simplicity while maintaining high standards of performance. This complete overhaul of eTMF Connect results in a quicker, more scalable, and efficient eTMF solution that is equipped to handle the evolving demands of clinical trials today and into the future. With the integration of advanced data visualization and reporting tools, Montrium has significantly enhanced the business intelligence capabilities of eTMF Connect. This new functionality provides project teams and clinical operations managers with deeper insights into TMF completeness, quality, and timeliness across all studies, allowing for improved visibility. Consequently, these upgrades will advance your TMF strategy within various clinical programs. Each clinical trial comes with its own set of challenges, and the unique intricacies and regional differences can create considerable complexity that may trouble even the most experienced TMF professionals. Therefore, it is imperative that your eTMF platform possesses the flexibility to tackle these diverse challenges effectively. Achieving this adaptability enables your organization to navigate the complexities of clinical trials with assurance and accuracy, ultimately contributing to more favorable outcomes. With these advancements, eTMF Connect positions itself as an indispensable tool for managing clinical trial documentation and ensuring regulatory compliance.

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

Montrium Connect

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
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Montrium

Company Location

Canada

Company Website

www.montrium.com

Company Facts

Organization Name

Court Square Group

Date Founded

1995

Company Location

United States

Company Website

www.regdocs365.com

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
HIPAA Compliant

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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