Related Products
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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.
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About
eDeviation supports all the operations for Protocol Deviation assessment and management. From software design and validation to collecting supporting documents and exporting data for the TMF, eDeviation® relieves your clinical team from the risks associated with missing or wrongly assessing one-time or recurring protocol deviations. eDeviation® is part of Ethical’s eClinical Software Platforms Solutions supporting faster and more accurate clinical trials management. Whether your protocol deviation assessments are performed by an independent expert committee or by your study team, our eDeviation® software is configured to exactly match your needs. Forms, workflows and exports altogether contribute to a GxP quality and effectively managed study. Study teams, Investigators’ Sites and Committee Members, when applicable, work seamlessly online in real-time to expedite judgments, consensus and timely completion of the protocol deviation assessments and management.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Clinical-operations, regulatory-affairs and quality-assurance teams searching for a tool to support studies, audits and global operations
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Audience
Clinical trials organizations seeking a solution to manage their operations
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationAgatha
Founded: 2015
United States
en.agathalife.com
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Company InformationeDeviation
www.protocoldeviation.com/eDeviation-software
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Categories |
Categories |
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Integrations
No info available.
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Integrations
No info available.
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