Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Agatha provides a comprehensive range of cloud-based solutions specifically designed for the life sciences sector, facilitating the centralized oversight of documents and processes related to clinical operations, quality assurance, regulatory compliance, and training activities. This platform caters to the workflows of biotech firms, pharmaceutical companies, medical device manufacturers, and contract research organizations by offering various modules, including eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, and tools for creating and approving standard operating procedures (SOPs) as well as managing quality documents related to CAPAs, deviations, and change controls. Additionally, Agatha enhances regulatory document handling, ensuring smooth document creation, review, approval, storage, and sharing within a single cohesive system. By promoting a paperless approach, it alleviates administrative burdens and bolsters data security, while being constructed on a global-compliance framework that meets critical standards such as 21 CFR Part 11, GDPR, and EU Annex 11. Ultimately, Agatha empowers life sciences organizations to optimize their operations and maintain compliance with industry regulations more efficiently.
Description
Kivo offers an innovative solution for sponsors and CROs, providing an economical document and process management platform that enables life sciences teams to efficiently accomplish their tasks within a single, user-friendly, and compliant environment. By integrating DMS, RIM, QMS, eTMF, and eCTD functionalities, Kivo allows teams in pharmaceuticals, biotechnology, medical devices, and biologics to handle regulated documents, quality management activities, clinical trial documentation, regulatory submissions, and workflow processes without the hassle of using multiple disconnected tools. With Kivo’s Document Management System, users can manage controlled documents and automate processes while ensuring project oversight, corporate documentation, and readiness for due diligence in a centralized manner, featuring version control, collaboration tools, audit trails, search capabilities, workflow automation, and Part 11-compliant electronic signatures. Additionally, the RIM system enhances project management and correspondence, facilitates submission building and publishing handoff, provides eCTD viewing options, and streamlines dossier management and interactions with health authorities. Overall, Kivo equips life sciences teams with the necessary tools to maintain compliance and efficiency in their operations.
API Access
Has API
No
API Access
Has API
Yes
Integrations
Docusign
No
Gmail
No
Jama Connect
No
Jira
No
Microsoft 365
No
Microsoft 365 Copilot
No
Microsoft Excel
No
Microsoft SharePoint
No
Microsoft Word
No
Integrations
Docusign
Yes
Gmail
Yes
Jama Connect
Yes
Jira
Yes
Microsoft 365
Yes
Microsoft 365 Copilot
Yes
Microsoft Excel
Yes
Microsoft SharePoint
Yes
Microsoft Word
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Agatha
Founded
2015
Country
United States
Website
en.agathalife.com
Vendor Details
Company Name
Kivo
Founded
2021
Country
United States
Website
kivo.io
Product Features
Product Features
Document Management
Access Controls
Yes
Archiving & Retention
Yes
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
Yes
Document Capture
Yes
Document Conversion
Yes
Document Delivery
Yes
Document Indexing
Yes
Document Retention
Yes
Electronic Signature
Yes
Email Management
Yes
File Recovery
Yes
File Type Conversion
Yes
Forms Management
Yes
Full Text Search
Yes
Offline Access
Yes
Optical Character Recognition
No
Print Management
Yes
Version Control
Yes