Product Overview
Upgrade your onsite monitoring approach and replace it with Agatha’s secure, remote, electronic Investigator Site File (eISF). Our eISF solution streamlines the document collection and quality management for clinical trial sites while offering seamless exchange of regulated research documents.
Planning to diminish time and expenses associated with the monitoring of your clinical trial sites? Our eISF solution presents a superior model, negating the need for on-site visits and reducing the administrative burden.
Bring uniformity to your clinical research sites with Agatha’s eISF
Utilize Agatha’s eISF solution to simplify your clinical trial process, maintaining audit-ready essential study documents. Achieve remote access to all critical trial documentation and promptly identify missing records, ensuring a compliant conduct of your trials.
Agatha’s eISF solution empowers monitors and inspectors to review source files, make notes, and complete their monitoring tasks, contributing to an efficient clinical trial process. The application also facilitates the creation and assignment of tasks for site administrators, enhancing the communication between technology systems.
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.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
There’s More to Agatha Remote eISF
Custom Forms and Rendering: Leverage forms to drive processes based on metadata and use metadata to generate renditions.
Basic Preview and Annotations of essential site documents: Preview and annotate PDF and Office documents, and image.
Cross Workspace Reporting: Create views and reports across workspaces and export results to Excel for dashboard reporting.
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 control easily.
Advanced Integration Toolkit: Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation and sample code).
About the company
Virtually all clinical and compliance solutions are based on traditional document management approaches. You know, check-in, check-out, yada yada. Agatha breaks the mold with better technologies to deliver a solution to manage end-to-end processes, not just documents. Agatha’s founders, saw firsthand that clinical and compliance solutions available in the market are built on excessively complex platforms and took far too long to bring to productive use. Lead times for implementing these unwieldy and costly systems are often as long as six months.
Clinical trials and compliance processes are the bridge between developing new drugs, devices, and therapies and getting them to the patients who desperately need them. Every day managing trials and compliance activities mean another day before a new drug or treatment is available to patients.
They set out to prove that a new class of cloud-first, ready-to-use applications could shorten the time required to get critical new drugs and treatments to patients.
