The industry's most powerful eTMF

Start up more studies, faster than ever. Get the electronic trial master file software that’s simple to set up and easy to use, with built-in workflows that increase compliance.

Montrium eTMF / eTMF Connect

Built for:

Providing non-profit a seat at the table
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Giving your CRO teams a strategic advantage
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Allowing drug and device sponsors to level up
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Supercharge your study

eTMF Connect gives you an overview of all your TMF-related activities. Study information and TMF documentation are organized in one place, so you always know what you should do next.

Get better oversight

The eTMF Navigator reveals the items that need attention. Once you’ve identified missing or expected documents, you’re able to drag and drop directly onto these placeholders, updating completeness in real-time.

Transform study management

Centralized & unified

eTMF Connect places agility and intelligence at the forefront of its functionalities, allowing you to build out your processes in a way that makes sense for your unique environment. It’s centralized and unified, enabling all study stakeholders to collaborate on workflows and content in one easy-to-access place.

Improve access to information during site monitoring

Collaborate through user-configurable workflows

Centralized content and milestone management

Effortlessly align your documentation with the TMF Reference Model

Create better inspection experiences

Easy to use, easy to train

eTMF Connect goes beyond simply improving inspection readiness to improving the entire inspection experience. Its intuitive interface means that you’ll be able to train an inspector in the system in no time, saving you valuable hours and alleviating unnecessary stressors during an inspection.

Centralized records centre allows for seamless review by regulatory agencies

Cloud-based and globally accessible to remove friction

Specialized inspector portal enables easy system access

Easily apply filters to help navigate the TMF

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Empower a remote workforce

Enable decentralized clinical trials

Never in history has it been more business critical to have tools that facilitate remote collaboration. With eTMF Connect, team members across the globe can securely access and contribute to the trial master file with ease, improving inspection readiness and regulatory compliance.

View information wherever and whenever in a cloud-based application

Access the system from your web browser or device

Email documents directly to the TMF with the clinical inbox

Get real-time study intelligence

Powerful reporting & dashboards

You can't fix an issue if you don’t know it exists. With eTMF Connect, you’ll be able to access powerful reporting features and real-time dashboards that allow you to detect problems before they grow into inspection findings.

Apply filters and dimensions to intuitively navigate your TMF documents

Monitor TMF completeness and artifact status in real time

Set up smart dashboards that drive business intelligence and give real time oversight

Automate tmf management activities

More than just a document repository

Unlock extra hours in the day with features that put even the most tedious of TMF management activities on autopilot. When it comes to things like drafting, reviewing, and approving essential documents, eTMF Connect does the heavy lifting so that you can focus on what matters most, your clinical trials.

Draft from centralized document templates

Approvals and electronic signatures

Always-on content syncing


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Implementation methodology

We’ve developed a tried and tested methodology for implementing our platform, designed to reduce burden and speed up timelines while maintaining compliance.

Explore core functionality

Looking for more information on what bells and whistles to expect in Montrium eTMF? Explore the full breadth of functionality provided here.

Explore the Montrium platform

Montrium eTMF is part of the larger Montrium platform. Learn more about the industry’s leading intelligent content management platform.

A more intuitive home for your clinical trials

TMF planning software 

Move beyond the traditional TMF repository into the industry’s most robust and intelligent eTMF system. Improve TMF planning, TMF index development, and country and site management all from one interface. Transition from passive to active trial master file management today with the #1 eTMF system for scaling teams.   

Clinical trial management software 

Are today’s CTMS systems just glorified, fancy spreadsheets? What if you could manage a lot of the critical information you’d normally store in a CTMS side-by-side with your TMF documentation? Site and PI directories, country and site milestone tracking sitting next to your expected document list and dynamic placeholder management. 

TMF archive software

Get the best of both worlds with Montrium’s industry-leading trial master file solution for active and ongoing studies while getting the peace of mind that your closed studies are stored securely in our TMF archive, readily available at the drop of a hat. 

Site management software

Don’t let the site management burden get you down. The eTMF Connect system can be used to empower clinical sites to contribute documentation to the TMF in a timely manner, increasing efficiency and timeliness along the way. Montrium’s site management functionality streamlines collaboration with clinical sites, institutions, and medical practices to ensure a complete and inspection ready TMF at all times.

Inspection readiness solution 

Access better visibility into TMF inspection readiness with Montrium’s built in eTMF Navigator. Review trial master file completeness with dynamic placeholder management, keep an eye on timeliness metrics and stay focused on what issues may be affecting TMF quality today, all from a central dashboard.

Clinical document management software 

Improve author productivity for all study stakeholders with intuitive document template management, automated workflows and integrated digital signatures that are primed to enhance document management and development in your clinical program.

Upcoming live product showcases

Not ready to schedule a demo with our team? Attend a live product showcase and explore the Montrium platform with no strings attached.

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Try to change your choice

July 6, 2023
Improving the Efficiency and Timeliness of TMF Filing with eTMF Connect

Historically, TMF filing has had its fair share of challenges. Collaboration between partners, inefficient processes, lack of insight into important metrics, but most of all, manual, arduous, and painful. Let's take that process from headache to happy place with built in workflows, and easy to use filing and indexing features!

July 2023
Montrium eTMF
July 20, 2023
Leveraging Your QMS to Streamline Employee Onboarding & Training

Compliance drives everything that we do, and part of that process involves making sure that employees are trained on all SOPs, at all times. Sounds tedious, right? Not with a robust quality system in place!

July 2023
Montrium QMS
August 17, 2023
Drafting SOPs from Start to Finish with Review & Approval Workflows

Document lifecycles, version control, collaboration, approvals... Sound like a headache? It shouldn't be. This demo will showcase a streamlined and compliant approach to managing critical documents and data throughout their lifecycle

August 2023
Montrium QMS
August 31, 2023
Streamlining Author Productivity with Workflows in eTMF Connect

Traditional document management lacks the standardization, centralization, and robust processes needed to give you the peace of mind that your TMF is inspection ready. Leveraging review and QC workflows within eTMF Connect resolves this issue and also gives you some time back to do the things that you really need to do for trial management.

August 2023
Montrium eTMF
September 14, 2023
Stop Chasing Paper Forms and Digitize Your Change Control Process

Where is that change control form? Whose desk is it sitting on? Who needs to sign it? Why does it take forever to close out a change control request? Sound familiar? Let's take a look at how our Change Control module can digitize and streamline this critical process.

September 2023
Montrium QMS
September 28, 2023
Make Better Decisions with Dynamic Real-time Reporting in eTMF Connect

Is your manager asking you for study KPIs again? Or maybe the sponsor you are working with is looking for increased oversight on an all-important study? Whatever the case, let's take a look at some of the built-in reporting of eTMF Connect.

September 2023
Montrium eTMF
October 12, 2023
Reporting Quality Events & Initiating CAPAs in Quality Connect

Deviations happen. So do dropped boxes. Audits and complaints, too. Let's look at how we can track all of these events in one centralized location, and how we can manage the CAPA process if need be!

October 2023
Montrium QMS
01 / 05

FAQs about our eTMF system

What is an eTMF?

Electronic trial master file (eTMF) software or electronic TMF is a type of specialized content management system used for managing clinical trial documents across the lifecycle of the clinical trial. Its key purpose is to help organizations create an accurate retelling of the clinical trial through simplifying and expediting the process of authoring, filing, QCing, reviewing, organizing, and archiving clinical documentation. eTMF software makes it easy for regulatory authorities to obtain a comprehensive historical overview of the actions taken over the course of the clinical trial, allowing organizations to demonstrate compliance with GxP and other applicable regulations.

How long does eTMF implementation take?

The eTMF implementation process can vary in length depending on a number of factors. It comes down to considerations such as the size of your organization, the number of studies in progress, the amount of documentation that needs to be migrated, your IT department’s validation process, and others. However, on average we see most implementations of our products take roughly 30-60 days.

Is an eTMF different from a CTMS?

Yes, an eTMF is different from a clinical trial management system (CTMS). A CTMS is a study management tool that helps to keep track of information about countries, sites, investigators, subjects, milestones, and more. However, a CTMS isn’t designed for managing clinical documentation—which is where an eTMF comes in. An eTMF system comes loaded with all of the document management, workflow, and metadata tracking capabilities necessary for executing efficient and effective clinical documentation practice throughout the trial.

How can sites upload their documentation to eTMF Connect?

eTMF Connect makes it incredibly easy for sites to upload or email their TMF artifacts into the system thanks to a dynamic clinical inbox. eTMF Connect allows you to create inboxes for clinical sites and external partners, enabling them to email their documents directly to the TMF and maintain their electronic investigator site file. 

Can I follow the TMF Reference Model in eTMF Connect?

Yes. eTMF Connect is fully aligned with the latest version of the TMF Reference Model, meaning that our system can seamlessly generate a study TMF structure based on a global standard as well as in accordance with ICH GCP essential documents, and other regulatory requirements.

What is the difference between TMF and eTMF systems?

TMF or Trial Master file is a regulatory requirement that ensures drug and device sponsors tell an accurate story how the clinical study was conducted, traditionally through manual paper based systems. An eTMF or electronic trial master file is a system that is designed to digitize all of the documentation created by clinical trial stakeholders and store electronic records collected during clinical trial. Ultimately the electronic trial master file and the TMF remain the same, however eTMF solutions manage these documents electronically.

Can I archive my completed studies in eTMF Connect?

eTMF Connect can be leveraged by teams looking to implement an active TMF management methodology or those who are taking their first steps into electronic systems. Many of our customers leverage eTMF connect for digital content archiving as well for managing tmf documents as part of active clinical trials. Start by bringing in your completed studies to improve inspection readiness today, and explore our collaborative functionality as your clinical trial programs expand.

What reporting is available within eTMF Connect?

eTMF Connect provides study teams with robust and granular reporting to get to the bottom of issues that relate to your TMF content. Users can review TMF completeness and identify missing documents, report on full audit trails for traceability and transparency, review quality metrics like rejection rationale, and keep track of TMF timeliness.

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