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