Overview
What is Agatha Applications?
Agatha Applications provide software solutions for managing clinical operations, quality management, and regulatory processes for small and early-stage companies. These solutions cater to clinical operations leaders, quality managers, regulatory experts, and professionals in the pharmaceutical, biotech,...
Pricing
Basic
$9,950
Entry-level set up fee?
- No setup fee
Offerings
- Free Trial
- Free/Freemium Version
- Premium Consulting/Integration Services
Product Details
- About
- Tech Details
What is Agatha Applications?
Agatha Applications provide software solutions for managing clinical operations, quality management, and regulatory processes for small and early-stage companies. These solutions cater to clinical operations leaders, quality managers, regulatory experts, and professionals in the pharmaceutical, biotech, and pharmaceutical industries.
Key Features
Clinical eTMF: This feature offers a comprehensive solution for managing essential documents in clinical trials. It ensures document accountability, inspection readiness, and regulatory compliance. The feature provides a centralized platform for efficient document management.
Remote ISF: This feature eliminates the need for on-site monitoring visits, enabling remote monitoring activities and facilitating collaboration and communication among stakeholders. It provides remote access to essential documents.
Agatha SOP: Agatha SOP tracks and collects every activity and signature, ensuring process completion. It offers a comprehensive set of documents and records for audits and helps maintain compliance with standard operating procedures. The feature streamlines SOP tracking and management processes.
Quality Management: This feature captures complaints and deviations, documents corrective and preventive actions, and manages change control processes. It provides a comprehensive quality management system that connects actions and steps.
Agatha Regulatory: Agatha Regulatory tracks and manages regulatory documents across offices and countries, eliminating duplicate content and improving visibility into regulatory activities. It helps reduce non-compliance risks and streamlines regulatory processes.
Pharma QMS: Pharma QMS is designed for the pharmaceutical industry, providing a tailored quality management system. It ensures product quality, regulatory compliance, and offers a platform for continuous improvement.
QMS software: This feature offers software for streamlining and automating quality management processes. It provides tools for capturing, tracking, and managing quality-related activities and documentation, improving efficiency and compliance.
Biotech QMS: Biotech QMS addresses the unique quality management requirements of biotech and pharmaceutical companies. It ensures product quality, regulatory compliance, and provides a platform for continuous improvement.
Agatha Applications Features
- Supported: 21 CFR Part 11 Compliance
- Supported: Data Import/Export
- Supported: Document Management
- Supported: EMR/EHR
- Supported: HIPAA Compliant
- Supported: Workflow Management
- Supported: Alerts/Notifications
- Supported: Compliance Management
- Supported: Forms Management
- Supported: Access Controls/Permissions
- Supported: Activity Tracking
- Supported: Audit Trail
- Supported: Document Storage
- Supported: Drag & Drop
- Supported: Third Party Integrations
- Supported: Audit Management
Agatha Applications Technical Details
Deployment Types | Software as a Service (SaaS), Cloud, or Web-Based |
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Operating Systems | Web-Based, Mac, Windows, Linux, Chromebook |
Comparisons
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Reviews
Community Insights
- Business Problems Solved
- Pros
- Cons
Agatha Clinical has proven to be a reliable solution for centralizing clinical documentation while complying with local regulations. Users have been able to access their documents remotely, ensuring that no information is missing. The platform's efficiency and adaptability make it easy for users to adopt and navigate. Agatha Clinical's eTMF application has been particularly useful in organizing study-specific documentation at all levels, facilitating collaboration both internally and with CROs. Users have praised the customer support team for their excellent service, describing them as responsive, helpful, and very professional. While some users may not find the system amazing, the consistent delivery of great customer service has left them satisfied with their choice to partner with Agatha. Overall, users have found Agatha Clinical intuitive and user-friendly, with continuous updates that introduce additional features and functionality.
Intuitive and User-Friendly Interface: Many users have praised the highly intuitive and easy-to-use interface of Agatha Applications. The improved user interface allows for efficient task performance, making it easier for employees to navigate and perform their duties.
Responsive Customer Support: Reviewers have consistently mentioned the helpfulness and responsiveness of Agatha's customer support team. This demonstrates the company's commitment to ensuring customer satisfaction by promptly addressing any issues or concerns that may arise.
Scalable and Flexible Platform: Several reviewers have highlighted Agatha Applications as a scalable and flexible platform, particularly beneficial for fast-growing companies. The Agatha team is known for responding quickly to product configuration requests and testing changes, allowing for a quick turnaround in implementing necessary changes to accommodate business needs.
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Lack of Detailed User Guide: Some users have expressed the need for a more comprehensive user guide with detailed steps and specifications, as they have forgotten important information learned during the demo and training sessions.
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Difficulty in Artifact Navigation: Users have found it challenging to locate the correct artifact needed to implement a specific document, indicating a navigation issue within the software.
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Chinese UI Support Issues: Several users have reported issues with certain features that work well in the English UI but encounter problems when using the Chinese UI. This suggests that there is room for improvement in providing better support for Chinese language users.