Agatha Clinical eTMF

1 review

Agatha Clinical is an electronic master file (eTMF) application that connects all trial participants and processes in a single, cloud-based application. Leveraging the TMF Reference Model, Agatha Clinical includes standard templates to help you get up and running quickly, reducing ramp-up time to hours and days instead of weeks or months. With configurable actions that allow you to capture processes in end-to-end workflows, Agatha Clinical provides a tool to enforce best practices, document all activities, and connect all study participants. The result is faster start-up, more consistent processes, and complete trial documentation ready for inspection at any time. Benefits - Inspection Ready Your Trial Master File is up-to-date at all times and ready for sponsors, CROs, sites, and most importantly, auditors and inspectors. - Fully Automated & Efficient Document creation, review, and approvals are fully automated to ensure efficient and effective execution of all trial activities. - Connected to Everyone Every authorized trial participant — sponsors, CROs, and sites — can connect to the eTMF without the need for cumbersome IT processes. Fully Compliant - Agatha Clinical is built around the industry-standard eTMF reference model and ensures that every document expected in the file is present. Features - Create and Manage Sites & Documents - Create and manage trial sites based on the TMF Framework. Combine documents and forms to accelerate study processes. - Access Workspaces and Tasks in the Dashboard - View all your workspaces for each clinical trial site in the dashboard and quickly see and access tasks assigned to you. Use the configurable views to inspect, verify, and identify gaps in the expected eTMF contract at any time. Agatha Clinical (eTMF) Advanced Forms - Work with ready-to-use standard forms and processes, or adapt them to support your needs. Forms include rich text fields that allow the addition of images and formatted text. Use the form designer to update the look and feel of your forms. - A single multi-part form supports all steps in a process. Reviews, approvals, and assignments for actions are also built-in. - Author and Edit Documents Directly in the App - Co-Author and edit Microsoft Word, Excel, and PowerPoint files directly in the application, without the need for a Microsoft Office license. Annotate PDF, Office documents, and images with a simultaneous review of documents. - Ensure Quality Checks Are Completed - Designate documents for the quality check process and track the quality review using custom views. Complete Metrics and Reporting - Get all the reporting you need with built-in dashboards and reports, and export reports for external reporting requirements. You can also create views and reports across workspaces and export results to Excel for dashboard reports. Plus: - Extended Template Sets - Collect feedback from sites with Post Market Surveys and collect consent documents with Informed Consent. - Advanced Policy And Access Management - Manage policies, associated roles, and access controls easily. - Advanced Integration Toolkit - Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code). Secure Cloud Agatha Applications are cloud-based, hosted in Agatha’s highly secure, highly reliant, high-performance, compliant, cloud environment. Three Editions: Standard, Extended, and Premium Some features are only available in Extended or Premium editions.

Agatha Quality

0 reviews

Effectively managing clinical, compliance, and quality processes is a mission-critical task at life sciences companies. Quality improvements accelerate and improve processes, while quality failures can result in huge costs and disruptions. Choosing the right solution to track quality processes is a critical decision. Agatha Quality is a complete, ready-to-use application for capturing deviations, documenting corrective and preventive actions (CAPAs), and managing change control processes. Every action is connected, from the initial issue to the new process, and every step is documented, reviewed, and approved. More than document management, Agatha Quality is an end-to-end quality management system. Combining forms, documents, and workflows, Agatha Quality is a complete toolset for quality managers, pre-configured and validated but easy to adapt to specific process requirements Benefits - An End-to-End Process - A complete, closed-loop process captured in an expanding form, from initial issue to preventative action. A Complete QMS - Capture deviations, CAPAs, change controls, and audit activities to cover every part of the quality process. Inspection-Ready - Create complete quality records with electronic signatures, recorded approvals, and audit trails, all ready for inspection. Full Compliance - A validated system that is compliant with GxP requirements, EU Regulations, and FDA 21 CFR Part 11. Key Capabilities - Complete Metrics and Reporting - Get all the reporting you need with built-in dashboards and reports, and export reports for external reporting requirements. - Cross Workspace Reporting - Create views and reports across workspaces and export results to Excel for dashboard reports. Advanced Forms - Work with ready-to-use standard forms and processes, or adapt them to support your needs. Forms include rich text fields that allow the addition of images and formatted text. Use the form designer to update the look and feel of your forms. - A single multi-part form supports all steps in a process from deviation to change control. Reviews, approvals, and assignments for actions are also built-in. Preview, Edit, and Annotate - Review and edit Word, Excel, and PowerPoint documents directly in the application (does not require an Office license). - Annotate PDF, Office documents, and images with a simultaneous review of documents. Complete Records - Get complete quality records with signatures and audit trails, ready for inspection. Agatha QMS is fully compliant with 21 CFR Part 11 and EU regulatory requirements. - Agatha’s quality management application is also fully integrated with other Agatha applications making it easy to create references between them (eg. A CAPA can reference an SOP). More Than an Online Record - QMS forms are built on a Word template. When the form is converted to PDF, it’s more than a simple screenshot of the form on the page. Instead, you get a signed electronic record that is a nicely formatted PDF. Also Advanced Integration Toolkit - Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code). Advanced Policy And Access Management - Manage policies, associated roles, and access controls easily. Secure Cloud - Agatha Applications are cloud-based, hosted in Agatha’s highly secure, highly reliant, high-performance, compliant, cloud environment. Three Editions: Standard, Extended, and Premium Some features are only available in Extended or Premium editions.

Agatha SOP

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Standard Operating Procedures (SOPs) and employee training documents are crucial to effective business operations, ensuring compliance with regulatory requirements during clinical trials. Managing both SOPs and employee records in one application simplifies the process and enhances overall job performance. This is where Agatha’s SOP management software comes into play. Initiate with Standard Operating Procedure (SOP) templates Review, approve and operate SOPs with clinical SOP management Monitor SOP compliance with clinical SOP management Controlled print – Clinical SOP management for paper copies

Agatha Regulatory

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Agatha Regulatory is a comprehensive, ready-to-use regulation management application that addresses the challenge of creating a unified set of submission documents from content that is often created in many locations, sometimes in many countries. Use the application to collect, organize, and manage regulatory documents prior to submission, providing a single and authoritative source for all required content. Benefits - Ready-to-Use - Cloud-based, preconfigured, validated and ready to use. Consistent, Complete - Based on the EDM Reference Model, it automatically identifies missing documents. Coordinated, Collaborative - Online review of documents with shared annotations as well as review & approval workflows. Validated, Compliant - Fully compliant with 21 CFR Part 11, as well as EU Regulatory Requirements. Agatha Regulator y Features - Preview, Edit, and Annotate - Review and edit Word, Excel, and PowerPoint documents directly in the application (does not require an Office license). Annotate PDF, Office documents, and images with a simultaneous review of documents. See What’s Missing - Identify missing submission items automatically at any point in the process. Advanced Forms - Work with ready-to-use standard forms and processes, or adapt them to support your needs. Forms include rich text fields that allow the addition of images and formatted text. Use the form designer to update the look and feel of your forms. - A single multi-part form supports all steps in a process. Reviews, approvals, and assignments for actions are also built-in. eCTD Integration - Get all the reporting you need with built-in dashboards and reports, and export reports for external reporting requirements. - Create views and reports across workspaces and export results to Excel for dashboard reports. Also: Advanced Integration Toolkit - Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code). Advanced Policy And Access Management - Manage policies, associated roles, and access controls easily. Secure Cloud - Agatha Applications are cloud-based, hosted in Agatha’s highly secure, highly reliant, high-performance, compliant, cloud environment. Three Editions: Standard, Extended, and Premium Some features are only available in Extended or Premium editions.

Agatha Remote eISF

0 reviews

Enhance Your Clinical Trial Setup and Documentation Procedures with Agatha’s Electronic ISF - Simplify site & study configuration with our eISF Craft separate, protected areas for each Site to handle its documents. Each site and study incorporates a complete set of placeholders for expected eISF documents. Apply configurable auto naming to maintain naming conventions adhering to trial standards and facilitate compliant document management. - Dashboard access: Efficient workspace & task management View all your workspaces for each clinical trial site in the dashboard and quickly see and access tasks assigned to you. Use the configurable views to inspect, verify, and identify gaps in the expected eTMF contract at any time. - Real-time sharing of binder contents Share binder contents (investigator site files, or eISF) in real time among monitors, sites, and sponsors. This enables remote document review and quality check in your clinical trial process, crucial for maintaining a steady flow of documents between sites. Utilize forms to communicate monitor notes and assign tasks to site personnel. - Regulatory compliance & quality check management Pinpoint documents for the quality check process and track the quality review using custom views. Take advantage of workflows with electronic signatures to meet all compliance requirements. Establish automated workflows to transition final clinical study documents to the Master TMF. Our eISF solution offers a secure document exchange platform that aligns with documentation requirements and trial conduct standards, boosting your trial oversight capabilities.