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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

Over the last several years, the Life Sciences industry has faced nearly $15 billion in fines and compliance-related settlements, making it critical for companies to adhere to pharmaceutical, medical device and biotech best practices. Efficient and effective management of clinical trials can also significantly impact the time, scope and budget for the development of a drug or medical device. With OpenText™ Clinical Trial Quality Management System (ctQMS), companies can remain compliant, reduce costs of records management and establish best practice through collaboration before, during and after the clinical trial lifecycle.

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 a clinical trial management system

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

No images available

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

OpenText
Founded: 1991
Canada
www.opentext.com/info/clinical-trial-management

Alternatives

Alternatives

Medidata

Medidata

Dassault Systèmes
Lockbox LIMS

Lockbox LIMS

Third Wave Analytics

Categories

Categories

Integrations

No info available.

Integrations

No info available.
Claim Agatha and update features and information
Claim Agatha and update features and information
Claim OpenText Clinical Trial Quality Management and update features and information
Claim OpenText Clinical Trial Quality Management and update features and information