RegDocs365

RegDocs365

Court Square Group
eTMF Connect

eTMF Connect

Montrium
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About

Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.

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 Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Pharmaceutical, biotech, life science, medical device vendors, and more

Audience

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

Support

Phone Support Supported
24/7 Live Support Supported
Online Not Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Per user, Per month
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

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

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 Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Court Square Group
Founded: 1995
United States
www.regdocs365.com

Company Information

Montrium
Canada
www.montrium.com

Alternatives

Alternatives

LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
Clinion eTMF

Clinion eTMF

Clinion
cubeCTMS

cubeCTMS

CRScube
Clienvo eTMF

Clienvo eTMF

Clinevo
LifeSphere CTMS

LifeSphere CTMS

ArisGlobal

Categories

Categories

Clinical Trial Management Features

21 CFR Part 11 Compliance Supported
Document Management Supported
Electronic Data Capture Supported
Enrollment Management Not Supported
HIPAA Compliant Supported
Monitoring Not Supported
Patient Database Not Supported
Recruiting Management Not Supported
Scheduling Not Supported
Study Planning Not Supported

Clinical Trial Management Features

21 CFR Part 11 Compliance Supported
Document Management Supported
Electronic Data Capture Not Supported
Enrollment Management Not Supported
HIPAA Compliant Supported
Monitoring Not Supported
Patient Database Not Supported
Recruiting Management Not Supported
Scheduling Not Supported
Study Planning Not Supported

Integrations

Crow Canyon Contract Management Supported
Montrium Connect Not Supported

Integrations

Crow Canyon Contract Management Not Supported
Montrium Connect Supported
Claim RegDocs365 and update features and information
Claim RegDocs365 and update features and information
Claim eTMF Connect and update features and information
Claim eTMF Connect and update features and information