when you can’t be there in person
Remote Monitoring & Quality Control for Sites
Remote Monitoring and Quality Management for Clinical Trial Sites
The traditional approach to monitoring and quality management of sites is expensive, time-consuming, and often impossible. Agatha provides a remote monitoring application that eliminates the need to conduct on-site monitoring visits.
Remote site monitoring is possible
Remote monitoring of clinical trials sites and virtual clinical trials has been a topic of conversation for a while but COVID-19 has forced the discussion and need to the forefront.
The ability for a Clinical Research Associate (CRA) to visit physical sites and conduct reviews is nearly impossible. The result has been a concerning lack visibility into what sites are doing. In some cases, non-COVID-related clinical trials are getting put on hold.
The good news is that there is a way to remotely monitor sites.
Empower Sites with Remote Monitoring
Agatha Remote Monitoring is a complete, ready-to-use, pre-validated cloud-based application that allows clinical sites to securely upload source files to a 21 CFR Part 11 and HIPAA compliant application.
It enables monitors and inspectors to review the source files, make notes, and complete their monitoring tasks. The application also allows for the creation and assignment of tasks for site administrators, including notifications and tracking.
Agatha Remote Monitoring Key Features
- Create separate, secure areas for each Site to manage their documentation
- Set up each new site and study with a complete set of placeholders for expected documents
- Configurable auto naming allows naming conventions aligned to study standards
- Share binder (investigator site files, or ISF) contents between monitors, sites, and sponsors to enable remote document review and quality check
- Use forms to share monitor notes and to assign tasks to site personnel
- Leverage workflows with electronic signatures to meet all compliance requirements
- Automatically move final documents to the Master TMF using automated workflows
The Benefits of Agatha Remote Monitoring
A complete, pre-validated system in the cloud, ready for you to start using within days.
Every site has its own secure space; Monitors can access multiple sites through a consistent interface.
Full compliance with regulatory requirements including HIPAA and 21 CFR Part 11.
Leverages the TMF Foundations Model to embed best practices
Enforces and documents work processes with review and approval steps with complete, configurable workflows.
Agatha applications are hosted in a highly secure, compliant cloud service.
Clinical eTMF
Inspection-ready Management of Essential TMF Documents and Records
Remote Monitoring
Remote Monitoring and Quality Management for Clinical Trial Sites
SOPs
Creation, Review, and Approval of SOPs and Employee Training Records
Quality
Quality Document and Process Management for CAPAs, Deviations, & Change Control
Regulatory
Easily Manage Regulatory Documentation Following the EDM Reference Model