RIMTrackWinWire Technologies
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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
With ever-changing national regulations, data standards, and complexities around preparing for regulatory submissions, regulatory affairs organizations in the healthcare and life sciences industry are convinced and driven towards smarter processes and intelligent systems to optimize costs, maximize accuracy and minimize timelines for the submission. Addressing the concern, regulatory information management, RIMTrack, is a cloud-ready artificial intelligence (AI) based new age regulatory information management system. It’s developed from scratch with the mission to help organizations to prepare submissions accurately and efficiently and by streamlining the regulatory processes related to tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and reporting across global sites and stakeholders. Integrate with existing RIM system and achieve complete end-to-end management of regulatory life cycle process.
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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
Clinical-operations, regulatory-affairs and quality-assurance teams searching for a tool to support studies, audits and global operations
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Audience
Life sciences and healthcare organizations requiring a regulatory information management and tracking solution
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Support
Phone Support
Not Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
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Online
Supported
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API
Offers API
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API
Offers API
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Screenshots and Videos |
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Pricing
No information available.
Free Version
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Free Trial
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Pricing
No information available.
Free Version
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Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
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Live Online
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In Person
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Company InformationAgatha
Founded: 2015
United States
en.agathalife.com
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Company InformationWinWire Technologies
United States
www.winwire.com/regulatory-information-management/
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Categories |
Categories |
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Integrations
Microsoft 365
Not Supported
Microsoft Azure
Not Supported
Microsoft Dynamics 365
Not Supported
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Integrations
Microsoft 365
Supported
Microsoft Azure
Supported
Microsoft Dynamics 365
Supported
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