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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
eProtocol serves as a comprehensive online platform dedicated to research compliance for various institutions overseeing human subjects, animals, biosafety, and other regulated studies. This system facilitates the development and electronic submission of protocols, as well as the workflows for committee review and approval, amendments, renewals, reporting of adverse events, automated routing and reminders, version control, meeting agendas and minutes, audit trails, and comprehensive reporting. Users such as investigators, coordinators, reviewers, and compliance administrators can efficiently monitor protocol statuses and access relevant records through a collaborative interface. The platform features specific modules tailored for IRB, IACUC, IBC, stem-cell research, chemical safety, radiation safety, controlled substances, and post-approval monitoring processes. eProtocol is specifically crafted to meet the needs of universities, research institutions, hospitals, academic medical centers, biotech and pharmaceutical companies, as well as governmental research agencies, ensuring a streamlined approach to compliance across diverse research environments. Additionally, it enhances the overall efficiency of regulatory processes, ultimately contributing to the integrity and safety of research activities.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
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Integrations
No details available.
Integrations
No details available.
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
Yes
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
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Agatha
Founded
2015
Country
United States
Website
en.agathalife.com
Vendor Details
Company Name
Key Solutions
Founded
1991
Country
United States
Website
www.keyusa.com
Product Features
Product Features
Alternatives
Alternatives
No Alternatives