eTMF (electronic Trial Master File)

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

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.
TMF Dashboard
General
My Favourites

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
TMF Manager
eSignature
Admin area

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
My Views
Archiving
Permissions

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

Compliance

  • 21 CFR Part 11 compliant
  • 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

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 сlient 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.

What they say about us

John Douglas Snowden
Senior Vice President of Technology Innovation at NCGS, Inc.
NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.
Tameo Kobayashi
Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.
Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.
Joshua Baisley, H.B.Sc.
VP, Clinical Design and Delivery
As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.

More about eTMF

Data integrity assessment according to ALCOA++: Flex Databases eTMF is fully compliant

Data integrity has always been a critical point during the development of eTMF systems. One of the industry’s latest standards is ALCOA++, and our eTMF module is 100% compliant with ALCOA++.

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Bioclever selected Flex Databases
BioClever selected Flex Databases eTMF and PM & Budgeting 

This fall BioClever, Spanish full-service CRO, and Flex Databases signed a contract for eTMF, Project Management & Budgeting and Time Sheets & Utilization implementation.

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CTMS & eTMF implementation – Flex Databases & FGK CRO case study

In this video, we’ll tell you about Flex Databases CTMS & eTMF implementation for FGK CRO.

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Faron selected Flex Databases eTMF to have better oversight for Faron sponsored studies

This summer Flex Databases and Faron, a Finnish biopharmaceutical company, signed a contract for eTMF implementation.

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Have we picked your interest?

Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.