The platform powering R&D at emerging sponsors & CROs

Montrium Connect is an intelligent content management platform providing the most cost-effective Clinical, Regulatory and Quality solutions for scaling life sciences organizations.

NON-PROFIT RESEARCH
Providing non-profit a seat at the table
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CONTRACT RESEARCH ORGANIZATIONS
Giving your CRO teams a strategic advantage
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DRUG & DEVICE SPONSORS
Allowing drug and device sponsors to level up
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Our suite of intelligent products

The Montrium Connect platform consists of three dynamic, powerful and intuitive products for managing regulated content, processes, and compliance in the life sciences. Our pre-configured applications enable our clients to work better and smarter. Use one, or use all three – your team will thank you, because we make tech that works for you, not the other way around.

Designed both for and with scaling life sciences organizations, our industry-leading eTMF software allows you to power every decision with real-time intelligence. eTMF Connect helps teams bettermanage clinical trial documentation by standardizing and centralizing your clinical records. With our agile, data-driven eTMF solution, you can say goodbye to growing pains as you expand your team and your pipeline.

  • An eTMF system that scaled alongside your organization
  • Intelligent features that create ironclad inspection readiness from the get go

Ensure that your organization is always one step ahead of compliance with Quality Connect. Our robust, cloud-based quality management software supports scaling life science organizations through technology, allowing teams like yours to tackle quality challenges head-on.Manage SOPs, training, CAPA, and change control in an innovative, easy-to-use environment forged from years of expertise.

  • Automated intelligent workflows to lessen administrative burden
  • Create a virtual quality HQ to centralize compliance operations

Our regulatory submissions management solution helps scaling life science organizations define a clear path to complete, compliant submissions. RegDocs Connect distills the complexities oftoday’s regulatory landscape, empowering your organization to focus on what matters most. RegDocs Connect allows you to streamline your regulatory documentation processes to ensure quality, submission-ready content every time.

  • Collaborative authoring reduces friction in the development process
  • Easily keep track of submissions with comprehensive archiving

Our service offerings

We don’t just sell products. We believe in partnerships and value ongoing collaboration with our clients.
Support and services have been in our blood since day one, and that’s not going anywhere.  

Platform Services

Taking the leap and investing in a new system can be scary, which is why we have a dedicated Platform Services team here to help you at every step of the way.

With their support, you’ll never miss a beat when it comes to implementing, validating, or migrating your new system. Connect with our Platform Services team and you’ll experience the customer service that our partners can’t stop talking about.

eTMF Services

Our eTMF Services are for organizations who have
the right software and want to ensure that they make
the most of it.

Whether it be TMF management, eTMF training, eTMF system administration, or eTMF documentation templates, we’ve got you covered. By partnering with our experts, you can rest easy knowing that your trial documentation processes are in the best of hands.

We are a customer-focused
organization

We’re people first - through and through - which is why we continuously prioritize finding the best solutions to our client’s greatest pain points. Lorem Ips

15
years in the life
sciences
30+
countries
reached
200+
companies
onboarded
11000+
satisfied
users
60+
experienced
employees

Feedback from our partners and clients

The biggest impact that Quality Connect has had on my day-to-day is managing review workflows hassle free, the ease of signing documents, and gaining visibility on the signature process.

Sonette O'Reilly

Document Control Specialist

Sonette O'Reilly

Document Control Specialist

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

Flynn Eldred

VP of Quality @ Biovie

The automation of training on SOPs and WIs, in addition to the automated periodic review system, has made a huge difference in our compliance initiatives and quality management processes.

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

“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

The biggest impact that Quality Connect has had on my day-to-day is managing review workflows hassle free, the ease of signing documents, and gaining visibility on the signature process.

Sonette O'Reilly

Document Control Specialist

Sonette O'Reilly

Document Control Specialist

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

Flynn Eldred

VP of Quality @ Biovie

The automation of training on SOPs and WIs, in addition to the automated periodic review system, has made a huge difference in our compliance initiatives and quality management processes.

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

“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

The biggest impact that Quality Connect has had on my day-to-day is managing review workflows hassle free, the ease of signing documents, and gaining visibility on the signature process.

Sonette O'Reilly

Document Control Specialist

Sonette O'Reilly

Document Control Specialist

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

Flynn Eldred

VP of Quality @ Biovie

The automation of training on SOPs and WIs, in addition to the automated periodic review system, has made a huge difference in our compliance initiatives and quality management processes.

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

“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

The biggest impact that Quality Connect has had on my day-to-day is managing review workflows hassle free, the ease of signing documents, and gaining visibility on the signature process.

Sonette O'Reilly

Document Control Specialist

Sonette O'Reilly

Document Control Specialist

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

Flynn Eldred

VP of Quality @ Biovie

The automation of training on SOPs and WIs, in addition to the automated periodic review system, has made a huge difference in our compliance initiatives and quality management processes.

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

“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

The biggest impact that Quality Connect has had on my day-to-day is managing review workflows hassle free, the ease of signing documents, and gaining visibility on the signature process.

Sonette O'Reilly

Document Control Specialist

Sonette O'Reilly

Document Control Specialist

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

Flynn Eldred

VP of Quality @ Biovie

The automation of training on SOPs and WIs, in addition to the automated periodic review system, has made a huge difference in our compliance initiatives and quality management processes.

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

Miya Johnson

Regulatory Affairs Specialist @ Seattle Childrens Hospital

“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

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.