· 2 min readLearn more →
Anna will be a part of the Virtual Meet the Exhibitors event.
Have a helicopter view of TMF 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.
Manage your daily eTMF activities with easy-to-use tools
Upload documents in seconds – email a document directly into eTMF, drag and drop, connect your computer through WebDAV or just browse and upload.
Have all your CTMS documents automatically filed into eTMF with direct integration.
Review, assign metadata, and distribute documents to a correct folder with eTMF Manager.
Be always ready to any audit
Choose a list of documents for review with My views tab.
Use inbuilt chat function to query and correct a document.
Have at your disposal archiving function, logs, and external access designated for inspectors, auditors, partners.
What sets Flex Databases apart
We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the client involvement and requirements
Complete data safety
We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world
Flex Databases is compliant with all major international and local regulations such as ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end-users. No installation required
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
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
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
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
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
Custom metadata setup and management
Various metadata structures templates
Metadata actions (e.g. notification on expiry date of the document)
Dynamic metadata reports