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Agatha Clinical (eTMF)

Connect sponsors, CRO staff, and site resources with automated processes for creating, managing, and tracking the Trial Master File (TMF).

Managing Clinical Trials is Complex

Clinical trials are complex projects. You are working with many participants, each with different responsibilities and working in different locations. That complexity is amplified by the process itself, which includes extensive document creation, review, and approval processes. You need a better strategy than using paper binders and processes managed through spreadsheets. You need an eTMF (electronic trial master file) application.  

Agatha Clinical etmf

Agatha’s eTMF Can Help

Agatha Clinical is an electronic master file (eTMF) application that connects all trial participants and processes in a single, cloud-based application.

Leveraging the TMF Reference Model, Agatha Clinical includes standard templates to help you get up and running quickly, reducing ramp-up time to hours and days instead of weeks or months.

With configurable actions that allow you to capture processes in end-to-end workflows, Agatha Clinical provides a tool to enforce best practices, document all activities, and connect all study participants. The result is faster start-up, more consistent processes, and complete trial documentation ready for inspection at any time.

With Agatha Clinical (eTMF) you are…

Inspection

Ready

Your Trial Master File is
up-to-date at all times and ready for sponsors, CROs, sites and, most importantly, auditors and inspectors.

Fully Automated

& Efficient

Document creation, review, and approvals are fully automated to ensure efficient and effective execution of all trial activities.

Connected to

Everyone

Every authorized trial participant
— sponsors, CROs, and site — can connect to the eTMF without the need for cumbersome IT processes.

Fully

Compliant

Agatha Clinical is built around the industry-standard eTMF reference model and ensures that every document expected in the file is present.

“The decision to move to an electronic TMF and move its management in-house was the right decision for us. With Agatha’s help, we were able to configure an eTMF application that supports our needs today and can adapt with us as our processes evolve.” 

Archita Sharma

Clinical Research Associate, InCarda

How Agatha’s eTMF Supports Your Clinical Trials

etmf view and edit docs

Create and Manage Sites & Documents

Create and manage trial sites based on the TMF Framework. Combine documents and forms to accelerate study processes. 

Access Workspaces and Tasks in the Dashboard

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.

etmf workspace view
etmf edit docs online

Author and Edit Documents Directly in the App

Co-Author and edit Microsoft Word, Excel, and PowerPoint files directly in the application, without the need for a Microsoft Office license. 

Ensure Quality Checks Are Completed

Designate documents for the quality check process and track the quality review using custom views.
etmf QA View

You Get More With Agatha Clinical (eTMF)

Custom Forms and Rendering

Leverage forms to drive processes based on metadata and use metadata to generate renditions.

Basic Preview and Annotations

Preview and annotate PDF, Office documents, and images.

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

Manage policies, associated roles, and access controls easily.

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 Clinical (eTMF) That Works for You

Clinical eTMF
Remote Monitoring
SOP application
Quality Management Application
Regulatory Application

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.

 

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