agatha remote isf
Reduce the need for on-site monitoring
Remote monitoring and quality management for clinical 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.
Improve your Monitoring Processes with Agatha
Manage Sites & Studies
Maintain a complete, pre-validated system with all sites and study documentation, following the TMF Reference Model.
Configured for You
Enforces and documents work processes with review and approval steps with complete, configurable workflows.
Your Site Binder are
up-to-date at all times and ready for sponsors, CROs, and, most importantly, auditors and inspectors.
Ensure Full Compliance
Maintain compliance with regulatory requirements including HIPAA, 21 CFR Part 11, and related regulations.
“Monitors would go out to sites and physically browse the documentation they needed access to and provide feedback to sites. Study coordinators and other site members were often there, and there was this feedback and interaction that you don’t get in a remote framework. We wanted to make sure that monitors felt like they could do their job properly even though it was remote and that we were mirroring monitoring procedures.”
Easy Site & Study Set Up
Create separate, secure areas for each Site to manage its documentation. Each site and study comes with a complete set of placeholders for expected documents. Use configurable auto naming to enable naming conventions aligned to study standards.
Access Workspaces and Tasks in the Dashboard
View all your workspaces for each site in the dashboard and quickly see and access tasks assigned to you. Use the configurable views to inspect, verify, and identify gaps eBinder at any time.
Share Binder Contents
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.
Manage Quality Checks & Compliance
Designate documents for the quality check process and track the quality review using custom views. Leverage workflows with electronic signatures to meet all compliance requirements and set up automated workflows to move final documents to the Master TMF.
There’s more to Remote ISF
Custom Forms and Rendering
Leverage forms to drive processes based on metadata and use metadata to generate renditions.
Basic Preview and Annotations
Cross Workspace Reporting
Create views and reports across workspaces and export results to Excel for dashboard reports.
Extended Template Sets
Collect feedback from sites with Post Market Surveys and collect consent documents with Informed Consent.
Advanced Policy and Access Management
Advanced Integration Toolkit
Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code).
Get the Edition of Agatha Remote ISF That Works for You
- Pre-validated functionality for core ClinOps processes
- Check-in, Check-out, and Version Control
- Electronic Signatures and Complete Audit Trails
- Flexible review and approval workflows
- Full compliance with 21 CFR Part 11 and related Regulations
- All Standard Features, Plus
- Advanced reporting with Metrics and Dashboards
- Live Co-annotation for simultaneous review of documents
- Custom forms capability
- Advanced, role-based access management
- Everything in Extended
- “In Application” Microsoft Word and Excel editing – No Word required
- Live collaborative authoring and editing
- Extended template sets for SOPs, Informed Consent, and more
- Integration toolkit with Rest API support
The best way to know if an Agatha Application meets your needs is to try it out. And good news – we offer a free trial.
Complete the form, select the application you would like to try and we’ll reach out to get you set up as quickly as possible.
Want a little more information on your trial process? Go here.