eTMF Connect

eTMF Connect

Montrium
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About

Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11.

About

Introducing the new eTMF Connect. Simplicity Without Compromise. We’ve re-engineered eTMF Connect for a faster, more scalable and higher performing eTMF solution for today and tomorrow’s clinical trial environment. Improved Data Visualizations & Reporting Views. Montrium now offers a range of new data visualization and reporting tools embedded into eTMF Connect, providing more powerful business intelligence applications. With functionality that provides better insight across all of your studies, project teams and clinical operations managers can have increased visibility on TMF completeness, quality, and timeliness. Together, these improvements will elevate your TMF strategy across clinical programs. No clinical trial is the same, and the subtle nuances and regional differences add layers and layers of complexity that can keep even the most experienced TMF professional up at night. Your eTMF platform needs to be flexible enough to manage these differences and nuances.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Clinical-operations, regulatory-affairs and quality-assurance teams searching for a tool to support studies, audits and global operations

Audience

Life sciences companies looking for a tool that can create, collaborate and manage clinical trial documentation electronically

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Agatha
Founded: 2015
United States
en.agathalife.com

Company Information

Montrium
Canada
www.montrium.com

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LifeSphere CTMS

LifeSphere CTMS

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Categories

Categories

Clinical Trial Management Features

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Integrations

Montrium Connect

Integrations

Montrium Connect
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