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.

The only platform built for scaling biotech & pharma

Since our inception, Montrium has been on a mission to provide emerging and scaling biotech & pharma with the tools they need to bring treatments to patients faster. Gone are the days where enterprise tech was reserved for big pharma and big biotech, providing much needed fuel for the companies that are driving innovation: the smaller companies.

Helping you hit milestones on-time and on-budget

With the cost of drug development continuing to rise, it’s even more important to ensure your program remains on-time and on-budget.
Not only do you have the pressure to deliver safe, effective drugs to patients, you must do so quickly and without compromising quality. Many of these challenges can be addressed by implementing systems that provide you with the functionality to standardize, the flexibility to scale, and the power to decrease timelines.

You need to:

Increase the speed in which you produce safe, effective drugs while maintaining quality

Avoid costly mistakes that slow down time-to-market

Ensure that timelines and budgets are respected and bring down the overall cost

Streamline the commercialization process and get treatments to patients faster

We have been extremely pleased with the guidance that we are being provided. We understood that it would be very important for us to find a platform that could grow with us as we progressed into Phase III.

Kimberly Swint

Manager of Clinical Trials Documentation

Introducing your new tech stack

Quality Connect

Quality Connect is a state-of-the-art electronic quality management system engineered specifically for small and mid-sized pharma, biopharma, and biotechnology organizations. Build a solid foundation centered on quality.


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. Bring TMF management in-house and take back control.


collaboration with stakeholders

Better study oversight

Upgraded inspection readiness

Centralized storage & management

Enhanced TMF strategy & planning

RegDocs Connect

RegDocs Connect is a full regulatory document management and submission planning platform designed to help leaner regulatory teams increase the quality and timeliness of regulatory submissions.


More visibility into submission readiness

More structured submission archiving

Centralization of documentation development

Improved collaboration with publishers & affiliates

Better content portability
& export

Proven technology
that addresses your business needs

We’ve built a comprehensive toolset of applications that are specifically built for emerging biotech and pharma. We understand that you need technology that enables you to get ahead today, but scales as study design complexity increases in the future. 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.
Adobe Validation
Learn more
Adobe Validation
eTMF Connect
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eTMF Connect

Adapt to the new way of working

The way we work has fundamentally changed. With teams more geographically dispersed than ever before, the tools we have relied on are no longer sufficient. Upgrade your digital workplace and empower people to work where they’re most productive, without compromising on quality or compliance.

100% web-based applications

Electronic archiving & access management

Accessible anywhere on & any device

Built-in compliance alignment

Fully-managed platform

Built for leaner teams

Rapid system implementation

IT & Security taken
care of

Resources for emerging pharma & biotech teams

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.