www.montrium.com Open in urlscan Pro
18.102.16.191  Public Scan

Submitted URL: http://montrium.com/
Effective URL: https://www.montrium.com/
Submission: On October 19 via manual from GB — Scanned from GB

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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

Learn more
Learn more


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

Learn more
Learn more


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

Learn more
Learn more





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.

Learn more




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.

Learn more





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.

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