eTMF in clinical trials

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

Product sheet PDF
compliant with FDA
ISO 27001_2022

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.
Product sheet PDF
TMF Dashboard

TMF Dashboard

General

General

My Favourites

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

TMF Manager

eSignature

eSignature

Admin area

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

My Views

Archiving

Archiving

Permissions

Permissions

Features

TMF Dashboard
  • Simple TMF template creation and configuration, including DIA Reference Model
  • E-mail blasts from TMF to sites
  • OCR – system recognizes 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
TMF Manager
  • 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
eSignature
  • 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
Permissions
  • 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
Archiving
  • 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
My Views
  • Custom metadata setup and management
  • Various metadata structures templates
  • Metadata actions (e.g. notification on expiry date of the document)
  • Dynamic metadata reports

What They Say About Us

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.

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.

Craig Winter

CIO, Agenus Inc.

I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done.

Cheryl Marron

Manager Clinical Operations

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Ulrike Schorr-Neufing

Director Personnel & Qualification

We have been using Flex Databases software for about 2.5 years now. One major advantage of Flex Databases CTMS is the ability to create specific reports ourselves. Additionally, we value that our feature requests are taken seriously by Flex Databases and added to their development roadmap. We also benefit from their customer-specific configuration service.

Martin Krauss

Director of FGK Clinical Research

FGK selected Flex Databases for CTMS and TMF due to clear structure, intuitive interface, flexible investigator payment module, offline access for CRAs, and positive cooperation with the Flex Databases’ team.

Simon Rückinger

Managing Director at Metronomia Clinical Research GmbH

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Maya Bhattacharya

Manager, Global Regulatory Affairs Operations

We knew Flex Databases was a game changer, providing confidence to what we could do next within the Clinical space, considering our trials/patients. SPARC choose Flex Databases due to system flexibility and checking the boxes for ALL of our major requirements. We also wanted the latest and greatest technology considering the long-term advantages of having one solution with the increased possibilities of integration.

Lídice Vidal

Chief Clinical Օperations Officer

We have made a journey of almost two years now, since we were exploring new vendors to change our CTMS system in May 2022, until the deployment of the system last March 2024. It would not be possible without the kind and patient support of Flex team! All the team we have encountered during this time have listened attentively to our needs and doubts, have perfectly understood them, and have always provided us with new options and possible solutions.

Have questions?

Drop us a line and we be happy to answer all your questions

100+

Clients

20 000+

Daily users

10M+

Documents

2 000+

Clinical trials

30+

Countries

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We are here for all of your questions! 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.