LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
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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

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.

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

Organizations that need an eTMF solution

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

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

Alternatives

Alternatives

LifeSphere CTMS

LifeSphere CTMS

ArisGlobal
LifeSphere EDC

LifeSphere EDC

ArisGlobal
eTMF Connect

eTMF Connect

Montrium
Lockbox LIMS

Lockbox LIMS

Third Wave Analytics
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
Clinion eTMF

Clinion eTMF

Clinion

Categories

Categories

Integrations

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS

Integrations

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS
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Claim Agatha and update features and information
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