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Implement business critical systems while minimizing the IT burden

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Trusted by thousands of life sciences IT professionals globally

Top information technology (IT) leaders leverage Montrium to hit their goals

every day
every week
every month

Monitor system availability & security

Fully managed platform with ironclad security and performance management

Experienced team of experts focused daily on threat detection and vulnerability management

Modern cloud stack to ensure maximum availability for your business teams

Manage user access & permissions

Modern user management and access control that minimizes the IT burden

Robust permission management to ensure your teams have access to only what they need to

Modern identity management and single-sign-on (SSO) support to improve user onboarding

Plan for releases, updates, & impacts

Software that’s tested at every step to minimize bugs and reduce IT headaches

Feature-flag release methodology giving flexibility to onboarding new functionality when it makes sense for your team

Comprehensive documentation with every release, reducing the impact of updates and releases

Document control can be an extraordinarily complex process, so we looked for a system that could automate as much as possible, while still providing robust oversight and transparency to all involved — and that’s what we found with Montrium.

Patrick Bailey

Director of Quality

An offering designed to lighten the IT burden

IT Leadership
Technical Support
Validation & Compliance
Security
Expert domain knowledge embedded into our platform 
Deep understanding & focus on regulatory compliance
Built with scalability from the ground up
24/7 technical support
Experienced & capable support team 
Dedicated resources who learn your business
Professionals that have walked a mile in your shoes
Traditional & risk-based validation supported 
21 CFR Part 11 compliance baked-in 
Comprehensive validation deliverables provided
Aligned with GDPR for data privacy compliance 
SOC2-aligned security practices 
Threat detection & monitoring systems 
Multi-factor authentication to ensure security 
Security monitoring systems 

Top resources for IT professionals

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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