Montrium by industry

Montrium by industry

No matter your industry, Montrium's suite of intelligent, e-clinical tech is built to support your evolving needs and trigger meaningful progress. Consider us your trusted sidekick as you aim for excellence. 

Tech that gives
nonprofits a seat
at the table

Without nonprofits driving clinical R&D, we wouldn’t be where we are today. The work you do is indispensable, and the technology you have access to should reflect that. Our clinical intelligence platform is built to lower the barrier of entry to modern, top-tier study and quality management for organizations just like yours—without exhausting your funding. Claim your seat at the table of the industry’s biggest players with a tech stack purpose-built for lean teams.

Continue to push
your therapeutic
mission forward

We believe that the size or resources of an organization shouldn’t dictate the quality of their clinical research. Non-profits deserve access to the same industry-leading technology as the big players, and we're here to provide it. With Montrium, you’ll be able to continue advancing your therapeutic mission on an intelligent platform designed to help lean teams achieve the highest quality of output. Let’s democratize clinical research, together.

You need to:

Provide comprehensive oversight to boards & stakeholders

Optimize your budget for measured funding

Showcase the value of your work in a crowded industry

Respect strict data privacy & security requirements

Facilitate collaboration across teams & departments

We realized very early on that to scale our Phase II successes in the next step of our journey, bringing in the appropriate technology to support this activity would be key. By partnering with Montrium, we not only leverage a sophisticated and robust eTMF system, but a knowledgeable and dedicated partner in the clinical trial arena.

Amy Emerson

Lykos Therapeutics

Introducing your new tech stack

Quality Connect

Quality Connect is a state-of-the-art electronic quality management system designed to provide nonprofits with the ability to create a high-calibre quality center. Building and maintaining a robust quality system not only puts a board’s mind at ease, but also showcases the seriousness with which you take your mission.


Streamlined document control

Improved training compliance

Better tracking of quality issues

Controlled change management

Increased quality & compliance

Win-win audit readiness

eTMF Connect

eTMF Connect is the leading electronic trial master file system for emerging clinical teams. With the TMF being a core deliverable to stakeholders and the keystone of your therapeutic mission’s success, it’s important to have a system that withstands the pressure without breaking the bank.


collaboration with sponsors & partners

Upgraded inspection readiness

Easy content export to sponsor teams
at closeout

Centralized storage & management

Enhanced TMF strategy & planning

Better sponsor oversight

Common metrics & KPIs

RegDocs Connect

RegDocs Connect is a full regulatory document management and submission planning platform that can help you ease the burden of the regulatory submission process in resource-constrained environments. Simplify and streamline the journey to compliant regulatory submissions with our leading RIM platform.


Better content portability & export

More visibility into submission readiness

Centralization of documentation development

Improved collaboration with publishers & affiliates

More structured submission archiving

Proven technology
that addresses your mission's needs

We’ve built a comprehensive toolset of applications that are designed to empower nonprofit organizations. We understand that you need technology that enables you to get ahead today and future-proofs your clinical program for success. Our platform has been battle tested over thousands of clinical studies across the globe, giving you piece of mind that Montrium can withstand the stress test of any clinical trial.

Adapt to a demanding industry

With budgets to manage, boards to please, and strict privacy measures to uphold, nonprofits have a lot on their plates. Give your organization a high-tech edge by investing in technology that juggles everything for you, allowing you to dedicate your time to what matters most: advancing your therapeutic mission.

GDPR-compliant from the ground up

Electronic archiving & access management

Built-in compliance alignment

Rapid system implementation

Fully managed platform

IT & security taken care of

End-to-end study management

Built for lean teams

Resources for emerging nonprofit organizations

White Paper
Clinical Operations
Building a Risk-based TMF Management Framework
In this first-of-its-kind white paper, Montrium's experts detail their new methodology for risk-based TMF management. It goes beyond simply explaining the theory behind risk-based approaches to providing worked examples that illustrate how you can implement this model within your own organization.
Clinical Operations
The State of TMF Industry Report 2023
The State of TMF Industry Report 2023 is the largest report of its kind, featuring proprietary data collected from 245 TMF professionals and analyses from Montrium's seasoned experts.
Clinical Operations
Guide to Sponsor vs CRO-owned TMF Systems
Our free guide breaks down the advantages and disadvantages of owning a sponsor eTMF system vs a CRO-owned eTMF system.
Clinical Operations
eTMF Request-for-Information Template
Our free RFI template helps get all of the critical criteria you need to evaluate eTMF software vendors.
Clinical Operations
Guide to Bringing TMF Management In-House
Discover what it takes to get from A-to-Z and manage your TMF internally with our free guide.
Clinical Operations
The Complete Guide to Buying eTMF Software
This guide will help select the right eTMF solution for your team with expert guidance and advice.
Clinical Operations
The Ultimate Checklist for Inspection Readiness
Our TMF checklist will provide you with a clear action plan as you prepare for your inspection.
Clinical Operations
COVID-19 and TMF Management Report 2020
The report includes the results of our COVID-19 and TMF Management Survey, with views representing a wide range of industry stakeholders, including pharmaceutical and biotech sponsors, and CROs.
Regulatory Affairs
The Complete Guide to Buying RIM Systems
This buyer’s guide is designed to help you step-by-step towards selecting the right regulatory EDMS solution and vendor.
GxP Software Vendor Selection Checklist
Not sure where to start when it comes to selecting the right software for your business? Check out this free checklist.
Clinical Operations
eTMF Business Case Template
Build a powerful business case internally for implementing an eTMF at your organization with our FREE template!
Clinical Operations
Template - Paper-based System Cost Calculator
Our customizable Paper-Based System Cost Calculator lets you input a few basic metrics, and in minutes can tell you the total annual cost of your paper-based system.
Quality Assurance
IT SOP Checklist for Life Science Companies
The SOP checklist includes a full list of procedural documents needed, information on their function and purpose, and how to get them in place.
Clinical Operations
eTMF Implementation Planning Workbook
This checklist has been designed as a self-guided preparation workbook to help your company plan a successful eTMF implementation.
White Paper
Quality Assurance
White Paper - 21 CFR Part 11 vs Annex 11
In this guide, we show you how to approach compliance around computerized systems using both directives, as well as how using GAMP 5 can level the playing field.
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Not sure where to start?

Not to worry, all this tech stuff can seem a little daunting at first. We’re here to help guide you and suggest the best solutions to suit your needs. Request some time to chat with our team and let us lighten the load.