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Pricing

Pricing and plans built for scaling life science teams

Explore the pricing options for all of Montrium's products below

eTMF Connect

Essentials

From   $999 / month
+ $55 / user per month

All prices are in USD
  • Low $10,000 Setup Fee
  • 100GB storage included
  • Up to 10 users
  • Unlimited studies & sites
ESSENTIALS includes:
  • TMF Document Management
  • Intuitive QC workflow
  • Built-in TMF Archive
  • Document placeholders
  • Batch upload & indexing
  • Aligned to TMF Reference Model
  • Built-in Reports
  • EU or NA hosting included
  • SSO Support
eTMF Connect

Growth

From    CUSTOM
+ per user fee per month
  • ACTIVATION FEE
  • 200GB storage included
  • No user limit
  • Unlimited studies & sites
Everything in ESSENTIALS +
  • Fully customizable workflows
  • 21 CFR Part 11 Electronic Signatures
  • Document Collaboration with Microsoft Word
  • Expanded reports library
  • Document template center
  • Premium customer support
  • Placeholder & index management
  • Dedicated Customer Success Manager
Quality Connect

ESSENTIALS

Build a solid foundation of quality.
+ Document Control Module
  • Automated workflows
  • Template management
  • Review & approvals
  • Word integration
  • Records archiving center
  • Electronic signatures
  • PDF conversion
  • Reports & KPIs
+ Training Management Module
  • Training matrix
  • Template management
  • Task automation
  • Training courses
  • Training quizzes
  • Gaps reports
  • KPIs & metrics
  • E-Learning content
Quality Connect

GROWTH

Scale quality processes to prepare for growth.
+ Document Control Module
+ Training Management Module

+ Supplier Management Module
  • Supplier Onboarding
  • Supplier Management Automation
  • Periodic Assessments of Suppliers
  • Suppier Record Storage
+ Audit Management Module
  • Observation Management
  • Audit Schedules
  • Task & reminder notifications
  • Reporting & KPIs
+ CAPA & Non-Conformance Module
  • Quality Event Reporting
    (Deviations, Complaints, Incidents etc)
  • Automated workflows
  • Task & reminder notifications
  • Reporting & KPIs
  • Action creation/tracking
  • Root cause analysis
  • Investigation management
Quality Connect

Enterprise

Support end-to-end quality excellence across the enterprise.
+ Document Control Module
+ Training Management Module
+ Quality Events / Incidents
+ CAPA Management

+ Change Control Module.
  • Automated workflows
  • Template management
  • Review & approvals
  • Word integration
  • Records archiving center
  • Electronic signatures
  • PDF conversion
  • Reports & KPIs
Regulatory Information Management Plaform

RegDocs Connect

The RIM platform built for leaner regulatory teams
  • 100GB of storage
  • Low monthly user fee
  • Unlimited products and submissions
  • One-time activation fee
Functionality included
  • Regulatory authoring
  • Customizable document workflows
  • Submission & sequence planning
  • Correspondence & commitment management
  • Built-in eCTD viewer
  • Regulatory submissions archive
  • Product information tracking
  • Document collaboration with Microsoft Word
  • Submission readiness reporting
  • Version control & audit trails
  • Document template center
  • Aligned and exportable in eCTD format
  • 21 CFR Part 11 Electronic Signatures
  • PDF/A conversion engine
Adobe Acrobat Sign Validation

free validation pack

Accelerate the validation of Adobe Acrobat Sign following a risk based approach
  • Full validation package for Adobe Acrobat Sign
  • Developed by Montrium
  • Leading validation methodology
  • Available for free
Accelerator Toolkit Includes
  • Validation plan
  • Regulatory Impact Assessment
  • System Requirements Specification
  • Validation Test Protocols & Scripts
  • Executed Test Scripts Summary Report
  • Work Instruction - Adobe Administration
Adobe Acrobat Sign Validation

ACCELERATOR TOOLKIT

Accelerate the validation of Adobe Acrobat Sign following a risk based approach
  • Accelerate Adobe Valdiation
  • Validate in as little as 2 weeks
  • Full documentation package
  • Leading validation methodology
Accelerator Toolkit Includes
  • Adobe Vendor Assessment
    Based on SOC2 Type 2 Reports produced by independent 3rd party auditors
  • Validation Summary Report
    Describing how the validation package from Adobe and test scripts executed by Montrium have been leverages
  • Electronic Signature Policy
    Policy template that can be adapted internally to your company
  • Employee ID Verification & Non-Repudiation Form
    Template that can be adapted internally to your company format
  • eSignature Notification for Health Authorities
    eSignature notification for regulatory authorities
Adobe Acrobat Sign Validation

Continuous validation

Continuous validation support as Adobe makes releases
  • Ensure Adobe Acrobat Sign remains validated
  • Ongoing software assurance subscription
  • Mapped to Adobe's release schedule
  • Endorsed by Adobe
Continuous Validation Subscription includes
  • Change impact evaluation
  • Updates to validation documentation
  • Execution of configuration verification
  • Functional verification test script execution
  • Access to validation experts
  • Fully documented process

Frequently asked pricing questions

What is unique about Montrium's pricing model?

We prioritize listening to our existing and future customers to deliver the best possible pricing model. We always endeavour to price our products in a way that aligns to the functionality our customers need in an easy to understand way that doesn't break the bank. We have pricing plans designed for organizations taking their first step into systems with no setup and implementation fees as well as more robust plans that provide functionality you'll need as you grow.

How can I go about getting a quote?

Getting a quote from us is as easy as filling out a short form. Complete the key information we need to provide you with pricing and a member of our team will reach out. Typically when requests for pricing are made we suggest a short call to refine the information we've gathered on your organization and fill in any gaps. Then we'll work with you to map out your evaluation process so you get everything you need.

How do I know what pricing plan is for me?

All of the high level information relating to the functionality you'll receive is provided in the pricing plans section above. This will already give you an indication of the plan that best suits your needs based on the functionality you'll need. If you're not sure which plan you need, fill out a pricing request above and a member of our team will guide you through the process to make recommendations.

What if I don't need all of the features in a pricing tier?

While our pricing plans are fixed, we always recommend booking a short call with a member of our team to walk through the different options. Often we're able to gather your requirements and make a recommendation that will best suit your needs.

Do all pricing plans offer customer support?

All of our pricing tiers include varying levels of customer support. Typically the more advanced the plan, the more intimate the support offering is. Reach out to a member of our team today through our pricing request forms and we'll be happy to share more details

Do your systems come pre-validated?

Montrium has developed a tried and tested validation approach to ensure our customers remain compliant and maintain the validated state. We pre-qualify the underlying platforms as well as rigorously test during our software development lifecycle to ensure the system meets its intended use cases. Additionally, we'll prepare of series of UAT test scripts that we run internally as an additional due diligence step. Customers are able to leverage all of this testing, verification and validation activity to implement a pre-validated system as well as execute validation deliverables provided by our team should that be required.

Feedback from our partners and clients

“eTMF Connect is a huge improvement. […] We went from one study to three studies, from one country to several, thereby more than tripling the number of clinical sites. It would not have been possible to scale the way we needed to without eTMF Connect.”

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Being able to really feel your impact as an employee is a testament to how much trust and space our leaders give us. We have a "we can do anything" mindset that drives us to produce great things. But at the base of why I love Montrium is the people - they're all brains and all heart.

Alison Robins

Content Marketing Manager

Alison Robins

Content Marketing Manager

Partnerships are critical to the success of our business. We've built a rich and vibrant partner ecosystem for our customers to take advantage of

Oliver Pearce

Director of Growth @ Montrium

Oliver Pearce

Director of Growth @ Montrium

When initially uploading documents and comparing them to the system’s placeholders aligned with the DIA’s TMF Reference Model, right away we could see in the eTMF Connect Navigator what was effectively complete, any documents we were missing, and any titles that needed to be named differently.

Gina Varner

Director of Regulatory Affairs

Gina Varner

Director of Regulatory Affairs

We’ve seen results in the form of reduced costs, time, and effort relative to training and documenting training. This was previously tracked with Excel spreadsheet training logs. Quality Connect allows one employee to manage the trainings and SOPs.

Maryann Böger

Clinical Systems and Quality Manager

Maryann Böger

Clinical Systems and Quality Manager

Not only is eTMF Connect a significant tool for sponsors’ trials, but it is also a modern approach for maintaining essential clinical trial documentation by HungaroTrial, as we are able to provide a high-quality, clean, transparent, up-to-date document management system to our clients, which greatly increases work efficiency.

Dr. Mátyás Pethő

Clinical Research Manager

Dr. Mátyás Pethő

Clinical Research Manager

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

Amy Emerson

Lykos Therapeutics

We chose to work with Montrium due to their expertise in the regulatory and technology landscape, understanding of our challenges, and quick responsiveness. We had less support when evaluating other companies.

Isabel Brosseau

IT Quality System Owner

Isabel Brosseau

IT Quality System Owner

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

Patrick Bailey

Director of Quality

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

Kimberly Swint

Manager of Clinical Trials Documentation

We really wanted a company to partner with who had that experience in our space, who understood the industry that we’re in, and who understood that we’re a small company in the process of growing.

Margaret Farrell

Director of Quality Assurance

Margaret Farrell

Director of Quality Assurance

“eTMF Connect is a huge improvement. […] We went from one study to three studies, from one country to several, thereby more than tripling the number of clinical sites. It would not have been possible to scale the way we needed to without eTMF Connect.”

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Being able to really feel your impact as an employee is a testament to how much trust and space our leaders give us. We have a "we can do anything" mindset that drives us to produce great things. But at the base of why I love Montrium is the people - they're all brains and all heart.

Alison Robins

Content Marketing Manager

Alison Robins

Content Marketing Manager

Partnerships are critical to the success of our business. We've built a rich and vibrant partner ecosystem for our customers to take advantage of

Oliver Pearce

Director of Growth @ Montrium

Oliver Pearce

Director of Growth @ Montrium

When initially uploading documents and comparing them to the system’s placeholders aligned with the DIA’s TMF Reference Model, right away we could see in the eTMF Connect Navigator what was effectively complete, any documents we were missing, and any titles that needed to be named differently.

Gina Varner

Director of Regulatory Affairs

Gina Varner

Director of Regulatory Affairs

We’ve seen results in the form of reduced costs, time, and effort relative to training and documenting training. This was previously tracked with Excel spreadsheet training logs. Quality Connect allows one employee to manage the trainings and SOPs.

Maryann Böger

Clinical Systems and Quality Manager

Maryann Böger

Clinical Systems and Quality Manager

Not only is eTMF Connect a significant tool for sponsors’ trials, but it is also a modern approach for maintaining essential clinical trial documentation by HungaroTrial, as we are able to provide a high-quality, clean, transparent, up-to-date document management system to our clients, which greatly increases work efficiency.

Dr. Mátyás Pethő

Clinical Research Manager

Dr. Mátyás Pethő

Clinical Research Manager

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

Amy Emerson

Lykos Therapeutics

We chose to work with Montrium due to their expertise in the regulatory and technology landscape, understanding of our challenges, and quick responsiveness. We had less support when evaluating other companies.

Isabel Brosseau

IT Quality System Owner

Isabel Brosseau

IT Quality System Owner

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

Patrick Bailey

Director of Quality

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

Kimberly Swint

Manager of Clinical Trials Documentation

We really wanted a company to partner with who had that experience in our space, who understood the industry that we’re in, and who understood that we’re a small company in the process of growing.

Margaret Farrell

Director of Quality Assurance

Margaret Farrell

Director of Quality Assurance

“eTMF Connect is a huge improvement. […] We went from one study to three studies, from one country to several, thereby more than tripling the number of clinical sites. It would not have been possible to scale the way we needed to without eTMF Connect.”

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Being able to really feel your impact as an employee is a testament to how much trust and space our leaders give us. We have a "we can do anything" mindset that drives us to produce great things. But at the base of why I love Montrium is the people - they're all brains and all heart.

Alison Robins

Content Marketing Manager

Alison Robins

Content Marketing Manager

Partnerships are critical to the success of our business. We've built a rich and vibrant partner ecosystem for our customers to take advantage of

Oliver Pearce

Director of Growth @ Montrium

Oliver Pearce

Director of Growth @ Montrium

When initially uploading documents and comparing them to the system’s placeholders aligned with the DIA’s TMF Reference Model, right away we could see in the eTMF Connect Navigator what was effectively complete, any documents we were missing, and any titles that needed to be named differently.

Gina Varner

Director of Regulatory Affairs

Gina Varner

Director of Regulatory Affairs

We’ve seen results in the form of reduced costs, time, and effort relative to training and documenting training. This was previously tracked with Excel spreadsheet training logs. Quality Connect allows one employee to manage the trainings and SOPs.

Maryann Böger

Clinical Systems and Quality Manager

Maryann Böger

Clinical Systems and Quality Manager

Not only is eTMF Connect a significant tool for sponsors’ trials, but it is also a modern approach for maintaining essential clinical trial documentation by HungaroTrial, as we are able to provide a high-quality, clean, transparent, up-to-date document management system to our clients, which greatly increases work efficiency.

Dr. Mátyás Pethő

Clinical Research Manager

Dr. Mátyás Pethő

Clinical Research Manager

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

Amy Emerson

Lykos Therapeutics

We chose to work with Montrium due to their expertise in the regulatory and technology landscape, understanding of our challenges, and quick responsiveness. We had less support when evaluating other companies.

Isabel Brosseau

IT Quality System Owner

Isabel Brosseau

IT Quality System Owner

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

Patrick Bailey

Director of Quality

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

Kimberly Swint

Manager of Clinical Trials Documentation

We really wanted a company to partner with who had that experience in our space, who understood the industry that we’re in, and who understood that we’re a small company in the process of growing.

Margaret Farrell

Director of Quality Assurance

Margaret Farrell

Director of Quality Assurance

“eTMF Connect is a huge improvement. […] We went from one study to three studies, from one country to several, thereby more than tripling the number of clinical sites. It would not have been possible to scale the way we needed to without eTMF Connect.”

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Being able to really feel your impact as an employee is a testament to how much trust and space our leaders give us. We have a "we can do anything" mindset that drives us to produce great things. But at the base of why I love Montrium is the people - they're all brains and all heart.

Alison Robins

Content Marketing Manager

Alison Robins

Content Marketing Manager

Partnerships are critical to the success of our business. We've built a rich and vibrant partner ecosystem for our customers to take advantage of

Oliver Pearce

Director of Growth @ Montrium

Oliver Pearce

Director of Growth @ Montrium

When initially uploading documents and comparing them to the system’s placeholders aligned with the DIA’s TMF Reference Model, right away we could see in the eTMF Connect Navigator what was effectively complete, any documents we were missing, and any titles that needed to be named differently.

Gina Varner

Director of Regulatory Affairs

Gina Varner

Director of Regulatory Affairs

We’ve seen results in the form of reduced costs, time, and effort relative to training and documenting training. This was previously tracked with Excel spreadsheet training logs. Quality Connect allows one employee to manage the trainings and SOPs.

Maryann Böger

Clinical Systems and Quality Manager

Maryann Böger

Clinical Systems and Quality Manager

Not only is eTMF Connect a significant tool for sponsors’ trials, but it is also a modern approach for maintaining essential clinical trial documentation by HungaroTrial, as we are able to provide a high-quality, clean, transparent, up-to-date document management system to our clients, which greatly increases work efficiency.

Dr. Mátyás Pethő

Clinical Research Manager

Dr. Mátyás Pethő

Clinical Research Manager

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

Amy Emerson

Lykos Therapeutics

We chose to work with Montrium due to their expertise in the regulatory and technology landscape, understanding of our challenges, and quick responsiveness. We had less support when evaluating other companies.

Isabel Brosseau

IT Quality System Owner

Isabel Brosseau

IT Quality System Owner

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

Patrick Bailey

Director of Quality

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

Kimberly Swint

Manager of Clinical Trials Documentation

We really wanted a company to partner with who had that experience in our space, who understood the industry that we’re in, and who understood that we’re a small company in the process of growing.

Margaret Farrell

Director of Quality Assurance

Margaret Farrell

Director of Quality Assurance

“eTMF Connect is a huge improvement. […] We went from one study to three studies, from one country to several, thereby more than tripling the number of clinical sites. It would not have been possible to scale the way we needed to without eTMF Connect.”

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Magali Lurquin

Senior Associate, Regulatory Affairs at Immune Biosolutions

Being able to really feel your impact as an employee is a testament to how much trust and space our leaders give us. We have a "we can do anything" mindset that drives us to produce great things. But at the base of why I love Montrium is the people - they're all brains and all heart.

Alison Robins

Content Marketing Manager

Alison Robins

Content Marketing Manager

Partnerships are critical to the success of our business. We've built a rich and vibrant partner ecosystem for our customers to take advantage of

Oliver Pearce

Director of Growth @ Montrium

Oliver Pearce

Director of Growth @ Montrium

When initially uploading documents and comparing them to the system’s placeholders aligned with the DIA’s TMF Reference Model, right away we could see in the eTMF Connect Navigator what was effectively complete, any documents we were missing, and any titles that needed to be named differently.

Gina Varner

Director of Regulatory Affairs

Gina Varner

Director of Regulatory Affairs

We’ve seen results in the form of reduced costs, time, and effort relative to training and documenting training. This was previously tracked with Excel spreadsheet training logs. Quality Connect allows one employee to manage the trainings and SOPs.

Maryann Böger

Clinical Systems and Quality Manager

Maryann Böger

Clinical Systems and Quality Manager

Not only is eTMF Connect a significant tool for sponsors’ trials, but it is also a modern approach for maintaining essential clinical trial documentation by HungaroTrial, as we are able to provide a high-quality, clean, transparent, up-to-date document management system to our clients, which greatly increases work efficiency.

Dr. Mátyás Pethő

Clinical Research Manager

Dr. Mátyás Pethő

Clinical Research Manager

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

Amy Emerson

Lykos Therapeutics

We chose to work with Montrium due to their expertise in the regulatory and technology landscape, understanding of our challenges, and quick responsiveness. We had less support when evaluating other companies.

Isabel Brosseau

IT Quality System Owner

Isabel Brosseau

IT Quality System Owner

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

Patrick Bailey

Director of Quality

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

Kimberly Swint

Manager of Clinical Trials Documentation

We really wanted a company to partner with who had that experience in our space, who understood the industry that we’re in, and who understood that we’re a small company in the process of growing.

Margaret Farrell

Director of Quality Assurance

Margaret Farrell

Director of Quality Assurance