Agatha Remote ISF

Agatha Remote ISF is an electronic Investigator Site File (eISF) solution developed by Agatha Corporation for the management of clinical site documents and associated processes. Designed for clinical trial sponsors, monitors, site administrators, and inspectors, it eliminates the need for paper binders by providing a centralized, remotely accessible platform for all essential study documentation. The solution is built to keep clinical study documentation audit-ready while reducing the administrative and logistical burden of traditional on-site monitoring visits.

By connecting monitors, sites, and sponsors through a remote monitoring environment, Agatha Remote ISF streamlines the clinical trial process and ensures compliant document management within a 21 CFR Part 11 and HIPAA-compliant application.

Key Benefits

• Elevated quality and reduced costs: The eISF solution reduces the time and expenses associated with monitoring clinical trial sites by negating the need for on-site visits and minimizing administrative overhead.
• Standardization across clinical research sites: Agatha Remote ISF brings uniformity to multiple research sites, enabling remote access to all critical trial documentation and allowing teams to promptly identify missing records for compliant trial conduct.
• Improved sponsor and site system interaction: Monitors and inspectors can review source files, take notes, and complete monitoring tasks efficiently. The platform also facilitates task creation and assignment for site administrators, enhancing communication between technology systems and stakeholders.

Main Features and Capabilities

• Site and study configuration: Create separate, protected workspaces for each clinical trial site to manage its documents independently. Each site and study includes a complete set of placeholders for expected eISF documents, with configurable auto-naming to maintain naming conventions aligned with trial standards.
• Task management: View all workspaces for each clinical trial site through a centralized dashboard, with quick access to tasks assigned to individual users. Configurable views allow teams to inspect, verify, and identify gaps in expected eTMF content at any time.
• Binder contents and real-time sharing: Share investigator site file (eISF) binder contents in real time among monitors, sites, and sponsors, enabling remote document review and quality checks. Forms are available to communicate monitor notes and assign tasks to site personnel.
• Quality check management: Pinpoint documents requiring quality review and track the process using custom views. Electronic signature workflows ensure all compliance requirements are met, and automated workflows can transition finalized clinical study documents to the Master TMF.

Compliance and Document Exchange

Agatha Remote ISF provides a secure document exchange platform that aligns with documentation requirements and trial conduct standards. The application is compliant with 21 CFR Part 11 and HIPAA, supporting robust trial oversight capabilities for life sciences organizations conducting clinical research.