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Product Overview
eTMF (electronic Trial Master File)
Have a helicopter view of eTMF processes at any point of time
Get instant safe access to your trial documentation from any place in the world.
See missing documents, files uploaded statistics, folder completeness by milestone or any other parameter.
Focus on the most relevant tasks with automated to-do lists, flexible widgets, and exportable reports.
Tools designed for your daily activities
Upload documents in seconds – email a document directly into eTMF or through an app on your phone, or drag and drop into eTMF, connect your computer through WebDAV or just browse and upload
Anything you prefer and used to works. eTMF integrated with CTMS, all CTMS documents are filed in eTMF with zero effort from you
Need one place to review, assign metadata and distribute documents to a correct folder? We got you covered with eTMF Manager space
Need to send documents in bulk to sites? Email it from eTMF with a track record
Review, approve, lock, sign, author documents with embedded eSignature function.
Simplicity without compromising quality
Periodic review of eTMF is finally easy with My views tab to choose a list of documents for review and use inbuilt chat function to query and correct a document
Inspection readiness is not a challenge anymore – it is a daily state of your eTMF
Regulations are met, validation is complete, audit trail is there
Archiving function, logs and external access designated for inspectors, auditors, partners is there too
No excessive training required
Specifications
General settings
Simple TMF template creation and configuration, including DIA Reference Model
E-mail blasts from TMF to sites
OCR – system recognize text in pictures, scans, photos
Online viewing and authoring via browser without download
Email alerts
Flexible access matrix
Web-based: no installation needed
The system can be hosted both cloud-based and on-premise
Single sign-on functionality is available using LDAP and SAML protocols
API is available for use in bidirectional integrations
System recognizes special /foreign characters
Compliance
Access control, based on project role, sites, folders, countries and for external users
Full Audit Trail and versioning
Easy archiving of eTMF project with index and audit trail
GDPR-compliant
Fully validated, all related documentation is provided
Upload
Automated filing of documents from CTMS
Email upload – send email with attachment directly to eTMF
Batch documents upload and download
Drag and drop function
TMF connected as an external drive through WebDAV protocol
Mobile application
Quality control
Adjustable notifications and alerts
My Views section – user-defined lists of documents based on metadata groups
QC Workflow for all file types, folders and placeholders
Chat and comments available for documents and folders
Documents review, approve, lock, sign configurable workflow and electronic signature
Reports
Real-time statistics on folders completeness
Business Intelligence: widgets and reports
Ad-hoc reporting tool for cross-project & cross-module reporting
Powerful search engine by various parameters in name and file content
Metadata
Custom metadata setup and management
Various metadata structures templates
Metadata actions (e.g. notification on expiry date of the document)
Dynamic metadata reports
Videos
Product Reference
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