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Submitted URL: http://montrium.com/
Effective URL: https://www.montrium.com/
Submission: On March 25 via manual from AE — Scanned from DE
Effective URL: https://www.montrium.com/
Submission: On March 25 via manual from AE — Scanned from DE
Form analysis
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Discover & access advanced features Request demo COMPANY AboutEventsNewsroomCustomersCareersContact us PARTNERS PartnersCo-marketing partnershipsTechnology partnersService partners Support EN FR Book a demo Get in touch Close BOOK A LIVE DEMO Schedule a demo with a representative. analytics_formname_demo_request_generic First Name* Last Name* Work Email* Phone Number* What products are you interested in reviewing?* * Electronic Trial Master File (eTMF) * Regulatory EDMS (RIM) * Quality Management System (eQMS) How did you initially hear about Montrium?*(e.g Webinar name, podcast, google search, colleague recommendation, linkedin) Are there any details we should know about your use case? Close REACH OUT TO OUR TEAM First Name* Last Name* Email Address* Company* Phone Number* Please let us know why you're reaching out* How did you initially hear about Montrium? Close BOOK A CONSULTATION CALL WITH AN EXPERT 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. Explore Montrium Explore Montrium NON-PROFIT RESEARCH Providing non-profit a seat at the table Learn More CONTRACT RESEARCH ORGANIZATIONS Giving your CRO teams a strategic advantage Learn More DRUG & DEVICE SPONSORS Allowing drug and device sponsors to level up Learn More 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 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 “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 CEO at MPBC Public Benefit Corporation Amy Emerson CEO at MPBC Public Benefit Corporation 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 CEO at MPBC Public Benefit Corporation Amy Emerson CEO at MPBC Public Benefit Corporation 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 CEO at MPBC Public Benefit Corporation Amy Emerson CEO at MPBC Public Benefit Corporation 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 CEO at MPBC Public Benefit Corporation Amy Emerson CEO at MPBC Public Benefit Corporation 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 CEO at MPBC Public Benefit Corporation Amy Emerson CEO at MPBC Public Benefit Corporation 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. First Name* Last Name* Email Address* Company* Phone Number* Please let us know why you're reaching out* How did you initially hear about Montrium? 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