Inspection-ready Management of Essential TMF Documents and Records
Agatha eTMF features
Create and Manage Sites & Clinical trial content
Forget paper documents: create and manage new TMF files based on the TMF Reference Model. Combine documents and forms to accelerate study processes.
Access Workspaces and Tasks in the Dashboard
View all clinical trials 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 content at any time.
Author and Edit Documents Directly in the Electronic Trial Master File
Co-Author and edit Microsoft Word, Excel, and PowerPoint files directly in the application, without the need for Microsoft Office.
Ensure Quality Checks Are Completed
Designate documents for quality checks and track the quality review process using custom views.
Agatha eTMF Benefits
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Benefit from easy remote collaboration & data collectionWith an eTMF, you can increase the performance of your TMF network, share lessons learned, and avoid duplicate info being uploaded via different channels. Agatha’s eTMF allows the study team to collaborate on the full life cycle of TMF management, from setup to archival. Documents can be uploaded by trusted users from any location. Desktop-based documents that are stored at the project home site can also be automatically uploaded in an Integrated Data Services file, accelerating each interaction with data. -
Secure online data storageThe use of reliable and efficient eTMF software allows for paperless offices, where hard copies are replaced with electronic files stored as part of a complete, electronic TMF. And eTMFs — which can be password-protected to provide secure storage of your employees’ documents — store files in a secure and reliable manner while providing easy access to data to different research teams. -
Track progress easilyClinical trial programs that protect data security and which are better at coordinating processes can minimize the barriers to adoption that many systems create. Being equipped to work in real-time on the documents required by trials can reduce the organizational burden of keeping up. An integrated, real-time tracking system gives people pertinent information when needed, wherever needed. -
Guarantee compliance to 21 CFR part 11Agatha’s eTMF provides systems and controls for compliance, such as audit trail, user account controls, archival policy and electronic signatures, as well as quality control tools. It uses process driven workflows for collect, store, share and synchronize data.
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