LifeSphere eTMFArisGlobal
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RegDocs365Court Square Group
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Related Products
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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.
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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.
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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
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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
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Audience
Organizations that need an eTMF solution
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Audience
Pharmaceutical, biotech, life science, medical device vendors, and more
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Not Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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PricingPer user, Per month
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Company InformationArisGlobal
Founded: 1987
United States
lifesphere.arisglobal.com/platform/clinical/etmf/
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Company InformationCourt Square Group
Founded: 1995
United States
www.regdocs365.com
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Alternatives |
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Categories |
Categories |
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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
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Integrations
Crow Canyon Contract Management
Not Supported
LifeSphere CTMS
Supported
LifeSphere EDC
Supported
LifeSphere RIMS
Supported
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Integrations
Crow Canyon Contract Management
Supported
LifeSphere CTMS
Not Supported
LifeSphere EDC
Not Supported
LifeSphere RIMS
Not Supported
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