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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.

pharma / biotech
CRO
medical device
nonprofit

Technology that gives
CROs a leg up 

As more and more clinical trials are being outsourced, the number of CROs in the market is scaling rapidly. Now more than ever, CROs must prioritize leveraging modern technology built with CROs’ unique needs in mind. Montrium’s cloud-based offerings allow CROs to easily add electronic document and quality management tools to their service portfolios. Now is the time to optimize your clinical operations and improve collaboration with sponsors – for the long haul.

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Gain a competitive edge in a crowded CRO market

Since the CRO market began, those that demonstrated experience and knowledge to deliver world class clinical programs in each therapeutic area were the groups that won project consistently and grew their businesses. While these tenets are still true today, with the volume of new organizations vying for sponsor attention increasing, forward thinking CROs are turning to technology to differentiate their offering and cut through the noise.

You need to:

Identify ways to optimize costs to win more bids & projects

Provide better oversight to your sponsor teams

Demonstrate quality and compliance excellence

Ensure that timelines & budgets are respected to keep sponsors happy

Augment your service offering to better support your customers

Montrium’s Validation Accelerator Toolkit for Adobe Sign not only saved us time, but also significantly reduced costs compared to managing and completing the validation process in-house

Flynn Eldred

VP of Quality @ Biovie

Introducing your new tech stack

Quality Connect

Quality Connect is a state-of-the-art electronic quality management system designed to provide CROs with the ability to create a quality center of excellence. Building and maintaining a better-quality system not only puts a sponsors mind at ease, but is testament to your customers on how you’ll handle their clinical program.  

UNLOCK:

Streamlined document control

Improved training compliance

Better tracking of quality issues

Controlled change management

Increased quality & compliance

Win-win audit readiness

View QMS modules
View QMS modules

eTMF Connect

eTMF Connect is the leading electronic Trial Master File system for emerging clinical teams. With the TMF being a core deliverable to your sponsors, protect sponsor investments, and safeguard the clinical program by centralizing clinical trial documentation in one place.

UNLOCK:

Improved collaboration with sponsors & partners

Better sponsor oversight

Upgraded inspection readiness

Centralized storage & management

Enhanced TMF strategy & planning

View eTMF functionality
View eTMF functionality

RegDocs Connect

RegDoc Connect is a full regulatory document management and submission planning platform that can help you augment your offering. Often the biggest bottleneck for CROs in expanding engagements with sponsors is the ability to support different activities. Add regulatory submissions to your service offering, powered by a leading RIM platform.

UNLOCK:

More visibility into submission readiness

More structured submission archiving

Centralization of documentation development

Improved collaboration with publishers & affiliates

Better content portability & export

View RIM functionality
View RIM functionality

Proven technology
that addresses your business needs

We’ve built a comprehensive toolset of applications that are specifically built for CROs. We understand that you need technology that enables you to get ahead today, but scales as study volume 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 of any clinical trial.
eTMF Connect
Immune Biosolutions
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Pharma/Biotech
eTMF Connect
eTMF Connect
Zydus Therapeutics
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Pharma/Biotech
eTMF Connect
Adobe Validation
Pharmascience
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Pharma/Biotech
Adobe Validation

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 CRO teams

Guide
Clinical Operations
CFO Pitch Guide
The CFO Pitch Guide is your playbook for executive conversations. Learn how to translate clinical tech benefits into CFO-ready messaging that drives clarity, confidence, and buy-in.
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Guide
Clinical Operations
TMF Toolkit
This TMF Toolkit is a curated collection of useful links, tools and resources compiled by TMF subject matter experts to support the TMF community. Whether you're new to the TMF space or a long-time pro, this living document is designed to grow with you. Bookmark it and check back often for new content and updates.
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White Paper
IT
Adobe Acrobat Sign-Shared Responsibilities for CFR 21 Part 11 and Annex 11 Compliance
In collaboration with Adobe, we’ve published a detailed white paper exploring how Acrobat Sign Solutions supports compliance with 21 CFR Part 11 and EU Annex 11, and what your organization must do to stay audit-ready. 
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Report
Clinical Operations
State of TMF Industry Report 2025
Read the report everyone's talking about! With insights from over 500 TMF professionals, you won't want to miss this.
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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.
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Report
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.
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Guide
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.
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Template
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.
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Guide
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.
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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.
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Checklist
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.
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Report
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.
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Guide
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.
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Checklist
Procurement
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.
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Template
Clinical Operations
eTMF Business Case Template
Build a powerful business case internally for implementing an eTMF at your organization with our FREE template!
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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.
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Checklist
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.
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Guide
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.
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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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pharma / biotech
CRO
medical device
nonprofit

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.

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