Remote ISF

Agatha Remote ISF is designed to streamline the management of clinical site documents and associated processes, eliminating the need for paper binders and standardizing clinical research sites. This eISF solution simplifies the clinical trial process, ensuring that all essential study documents are audit-ready and accessible remotely. It allows for easy identification of missing documents, enhancing the efficiency of clinical trials.

With Agatha Remote Monitoring, monitors and inspectors can review source files, take notes, and perform their monitoring tasks efficiently. The application supports task creation and assignment for site administrators, complete with notifications and tracking, all within a 21 CFR Part 11 and HIPAA-compliant framework.

Agatha Remote eISF Benefits

The solution helps elevate quality and reduce costs by minimizing the need for on-site visits and decreasing administrative burdens. It brings uniformity across clinical research sites and facilitates effective interaction between sponsor systems through remote monitoring.

• Remote access to critical trial documentation
• Efficient identification of missing records
• Enhanced communication between technology systems

Main Features

• Simplify site and study configuration with separate, protected areas for each site to manage documents.
• Task management with a dashboard view for quick access to assigned tasks.
• Real-time sharing of binder contents among monitors, sites, and sponsors.
• Quality check management with custom views and workflows using electronic signatures.
• Secure document exchange platform aligning with documentation requirements and trial standards.

Agatha's eISF solution offers a comprehensive approach to managing clinical trial documentation, ensuring compliance and boosting trial oversight capabilities.