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
Cloudbyz eTMF is a cloud-based solution that offers a repository of all clinical trials documents, including images, files, information, etc. Store, manage, and easily share all documents related to clinical trials in a digital format. Manage trial documents, remain inspection-ready, and provide real-time visibility to CROs and sponsors, as well as monitors and other stakeholders.
API Access
Has API
No
API Access
Has API
No
Integrations
Cloudbyz CTMS
No
Cloudbyz EDC
No
Cloudbyz PPM
No
Cloudbyz Safety and Pharmacovigilance (PV)
No
Integrations
Cloudbyz CTMS
Yes
Cloudbyz EDC
Yes
Cloudbyz PPM
Yes
Cloudbyz Safety and Pharmacovigilance (PV)
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
Quote based pricing. Please reach out to Cloudbyz for pricing details.
Free Trial
Yes
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
Yes
iPad App
Yes
Android App
Yes
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
Yes
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
Yes
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
Cloudbyz
Founded
2014
Country
United States
Website
www.cloudbyz.com
Product Features
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
Yes
Electronic Data Capture
No
Enrollment Management
No
HIPAA Compliant
No
Monitoring
No
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
No