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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
Only SAS offers a comprehensive, cloud-native environment for statistical computing in clinical research, featuring built-in analytic tools, adherence to data standards, and optional integrated analytic applications. This foundation enhances your capacity to modernize processes and expedite the introduction of new therapies into the market, ultimately contributing to improved health outcomes. By utilizing a collaborative platform, you can effectively manage and analyze information, streamline procedures, and provide trial results more efficiently to regulatory bodies. It serves as a unified solution for clinical analysis and submission, encompassing all necessary components for validation, compliance with regulations, version control, audit trails, and documentation assistance. The platform facilitates automation through customizable workflows, supports current and forthcoming integrations, and ensures the implementation and management of data standards and controlled terminology. Additionally, it features a central hub for all incoming data, automates data quality assessments, enhances data management practices, and prepares analytical data with greater accuracy, thus enabling more insightful outcomes. Ultimately, SAS equips clinical researchers with the tools needed to navigate the complexities of modern research and regulatory environments effectively.
API Access
Has API
API Access
Has API
Integrations
Python
R
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Agatha
Founded
2015
Country
United States
Website
en.agathalife.com
Vendor Details
Company Name
SAS
Country
United States
Website
www.sas.com/en_us/software/life-science-analytics-framework.html