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eTMF – complete 24/7 visibility into all your trial documentation

Advanced electronic trial master file management. Inspection readiness. Instant access.

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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.

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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.

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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.

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What sets Flex Databases apart

Easy implementation

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

Full compliance

Flex Databases is compliant with all major international and local regulations such as ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.

Flexible solution

Easily configure every part of our proprietary platform. The system is fully managed by end-users. No installation required

Features

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

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

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