Related Products
|
||||||
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 VideosNo images available
|
|||||
Pricing
No information available.
Free Version
Free Trial
|
Pricing
No information available.
Free Version
Free Trial
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Webinars
Live Online
In Person
|
Training
Documentation
Webinars
Live Online
In Person
|
|||||
Company InformationAgatha
Founded: 2015
United States
en.agathalife.com
|
Company InformationOpenText
Founded: 1991
Canada
www.opentext.com/info/clinical-trial-management
|
|||||
Alternatives |
Alternatives |
|||||
|
|
|
|||||
|
|
||||||
|
|
||||||
Categories |
Categories |
|||||
Integrations
No info available.
|
Integrations
No info available.
|
|||||
|
|
|