LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
RegDocs365

RegDocs365

Court Square Group
+
+

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About

LifeSphere eTMF is your clinical trial’s single source of truth. Discover a versatile solution that streamlines inspections, ensures compliance, and saves your organization time and effort. Built as the first system to support the TMF reference model, LifeSphere eTMF aligns Clinical documentation with regulations and study protocols in one solution. Create and manage a single source of truth for your clinical trial. Ensure trial master file quality, timeliness, and completeness with live collaboration and real-time document sharing. Streamline TMF inspections quickly and efficiently to handle any audit. Maintain compliance with embedded workflows and dashboards that allow easy trial reconstruction.

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.

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

Organizations that need an eTMF solution

Audience

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

Support

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

Support

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

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

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

Pricing

Per user, Per month
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 Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

ArisGlobal
Founded: 1987
United States
lifesphere.arisglobal.com/platform/clinical/etmf/

Company Information

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

Alternatives

LifeSphere CTMS

LifeSphere CTMS

ArisGlobal

Alternatives

LifeSphere EDC

LifeSphere EDC

ArisGlobal
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
eTMF Connect

eTMF Connect

Montrium
LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
cubeCTMS

cubeCTMS

CRScube
Clinion eTMF

Clinion eTMF

Clinion

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

Integrations

Crow Canyon Contract Management Not Supported
LifeSphere CTMS Supported
LifeSphere EDC Supported
LifeSphere RIMS Supported

Integrations

Crow Canyon Contract Management Supported
LifeSphere CTMS Not Supported
LifeSphere EDC Not Supported
LifeSphere RIMS Not Supported
Claim LifeSphere eTMF and update features and information
Claim LifeSphere eTMF and update features and information
Claim RegDocs365 and update features and information
Claim RegDocs365 and update features and information