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Average Ratings 0 Ratings

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features
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support

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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

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

Alternatives

Alternatives

No Alternatives
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