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We are Montrium

Our mission is as straightforward as it is ambitious: we want to modernize the way in which scaling life sciences organizations manage regulated content and compliance.
Oh, and we want to do it all without paper.  

Our mission

We believe that organizations (big and small) deserve solutions and services that are innovative, easy-to-use and collaborative. We believe in empowering growth with enabling and affordable tech. We know from experience that solid engineering and good design can be achieved without compromising compliance or increasing costs.

We seek to empower companies through industry-leading digital technology and unmatched industry experience. Why? Because we believe not only in our solutions, but in the people behind them and the people who use them. Our purpose is to support life sciences organizations in maximizing the effectiveness of their operations so that they can continue doing what they do best: helping others.

Culture & Values

Montrium isn’t a just technology company—it's also a people company.
Our people are at the core of everything we do. We believe in recruiting smart, passionate go-getters from all different backgrounds and providing them with the support they need to grow and excel.

We also understand that in order to continue being successful, we must provide the greatest value to all stakeholders involved. Whether it be our customers, our team members, our partners, or our community of followers, we aim to enrich and inspire. Our values as an organization and as a team are what drive us to meet these objectives.

Agility and constant improvement

We firmly believe in the continuous development of both our people and our products. We embrace change and mistakes as well as the learnings that come with them. We look ahead, and we encourage our customers to do the same.

People, over everything

We know we’re nothing without our people, and we mean that. Empowering both our employees and our customers to speak their minds is one of our top priorities.  We get human.

Collaboration

A collaborative dynamic and sense of partnership —both internally and with our customers — means everything to us. We function as a team.

Key milestones in our history

Montrium was founded as the result of a simple observation:
regulated electronic systems need to be better.

01 / 05

2005

Montrium is founded

Paul founded Montrium with a vision of re-engineering the way we collaborate and work on regulated content in the life sciences. Tevin Pathareddy and Michael Zwetkow soon joined the executive team, bringing with them a wealth of expertise in GxP processes, collaborative technology, and regulatory compliance. Together, they provided knowledge-based services to life science industries in need of support.

2007

Release of Montrium Connect Platform

The team releases Montrium Connect: an intuitive platform for document and quality management transforms the way users manage regulated content, while focusing on minimizing the need for custom development, configuration, and validation.

2012

Montrium expands to Europe

Montrium responds to growing market demands and opens a European office in Brussels, Belgium.

2014

Montrium partners with Microsoft

Montrium partners with Microsoft to develop set of guidelines for the use of Microsoft Azure in a GxP context. The new release of these documents sees alignment surrounding qualification deliverables recommended by GAMP within the IT Infrastructure & Compliance Good Practice Guide.

2014

Montrium Connect 3.0 launches

Montrium launches Montrium Connect 3.0, an enhanced document and quality management toolset for the new life science business model. A series of dynamic applications that are based on Microsoft SharePoint Technology, the platform has been developed to support cross organizational collaboration and process automation, with a strong focus on bringing both internal and external teams together in one collaborative platform.

2015

Montrium CEO launches the Exhange Mechanism Standard

CEO Paul Fenton launches the Exchange Mechanism Standard under the banner of the TMF Reference Model to improve clinical trial interoperability.

2016

Launch of Microsoft Azure Qualification Pack

Montrium helps life sciences companies move regulated applications to the Cloud with Microsoft Azure Qualification Pack, ultimately enabling life sciences organizations to implement and maintain compliant cloud-based solutions.

2016

Montirum releases eTMF Navigator

Montrium releases eTMF Navigator to provide more innovative business intelligence in clinical trials. The interactive intelligence dashboard integrated into eTMF Connect allows clinical teams to drive improvements in their processes, and better manage their clinical trials.

2017

Montrium releases Regulatory Navigator

Montrium launches Regulatory Navigator, homing in on regulatory submission tracking and planning. The interactive intelligence dashboard integrated is integrated into RegDocs Connect,  Montrium’s Regulatory EDMS. Equipped with powerful business intelligence and intuitive regulatory document management, Regulatory Navigator equips pharmaceutical organizations with the tools to significantly improve the quality of their content while speeding up their submission timelines.

2018

Montrium CEO presents on the TMF Reference Model in Europe

Montrium President and CEO, Paul Fenton, presents on the TMF Reference Model Exchange Mechanism at the HSRAA conference in Brighton England.

2018

eTMF Connect is relaunched

Montrium re-launches eTMF Connect with a focus on improved user experience. The updated eTMF Connect interface offers a completely re-engineered user interface aimed at simplifying processes without compromising eTMF functionality.

2019

Montrium partners with an AI firm

Montrium partners with a leading artificial intelligence firm to begin building a series of machine learning and NLP technology to improve clinical trial processes.

2020

FIrst annual TMF Week is launched

Montrium launches TMF Week 2020, a virtual summit for clinical operations leaders and TMF professionals around the globe, offering practical and thought-provoking insights on key industry topics and trends.

2021

Montrium secures $2M in funding

Montrium secures $2 million in non-dilutive funding from BDC Capital Growth and Transition Capital Division, to be used toward innovative product development and expanding the engineering team, poising Montrium for accelerated growth.

2021

TMF Week 2021

Montrium launches TMF Week 2021 for a second year with 40+ expert speakers and nearly 20 invaluable sessions that deep-dive into the ever-evolving world of TMF management and what all clinical trial professionals need to know.

2022

TMF Week 2022

Montrium launches TMF Week in 2022 for its third consecutive year, expanding its audience of TMF professionals and industry pioneers who tuned in from far and wide to the week-long virtual event.

2022

Montrium founders elected top healthcare leaders

Montrium co-founders Paul Fenton & Tevin Pathareddy named top healthcare leaders for 2022.

2022

Launch of eTMF Services & TMF Maturity training

Montrium announces the launch of both its expert-led eTMF Services and its new TMF maturity educational training designed to support clinical operations and TMF teams at every stage of the clinical development journey. Montrium’s team of seasoned TMF experts will support emerging businesses beyond eTMF implementation to realize their full potential.

2023

Paul elected to chair CDISC TMF Standards Group

Paul Fenton elected to chair the CDISC TMF Standards Group as part of the TMF Reference Model

2023

TMF Week 2023

Montrium launches their 4th annual TMF Week, a virtual conference dedicated to gathering thousands of TMF professionals and thought leaders from around the globe for a week of stimulating sessions and applicable learnings related to all things TMF.

Our team

The Montrium team is made up of leading industry experts, savvy entrepreneurs, tech mavens and creative minds, all working together to bring decades of experience and passion to our growing company.  

Paul Fenton

CEO of Montrium
Paul is responsible for having brought the Montrium vision to life. He has over two decades of experience in developing, deploying, and validating computerized systems for clinical trials, and has successfully led major clinical technology projects in both the EU and the Americas. He is an active clinical research and platforms industry contributor as both a longstanding member of the Trial Master File Reference Model steering committee and Chair of the CDISC TMF Standards working group. Paul likes to cycle and hike during his world travels where he searches for culinary inspiration to cook up at home.
LEADERSHIP

Michael Zwetkow

Chief Innovation Officer
For over 20 years, Michael has helped life science organizations around the world implement various technological solutions to improve their regulated processes. His role now involves aligning technological vision with business strategy to drive innovation in the Montrium organization. Michael not only brings expertise, creativity, and passion to exploring the life sciences, but also listening to and creating playlists from some of his favourite jazz, classical, alternative, old-school hip hop, and electronic artists.
LEADERSHIP

Tevin Pathareddy

Chief Technology Officer
Tevin has over 20 years of experience in the design, implementation, and validation of systems within regulated industries like the life sciences. He specializes in integrating processes, technology and people as he works to synthesize and transform business user requirements into technological solutions. When he’s not working, you can find him earning his CONCACAF B licence, playing or coaching soccer, or enjoying a cold microbrew. Ideally, it would be a combination of the latter two within the same afternoon.
LEADERSHIP

Oliver Pearce

Director of Growth Marketing
Oliver is responsible for leading global product marketing, advertising, brand, demand generation and communications strategies in order to maximize Montrium’s growth and market presence. With over a decade of experience in the life sciences and 15 years in the growth marketing space, Oliver believes his success is a byproduct of his team’s. When he’s not getting TMFs in shape, he likes to spend his time playing on Montrium's soccer team, golfing with the guys, and rucking around on the rugby pitch.
LEADERSHIP

Gianna de Rubertis

Director of Compliance
Gianna brings as much enthusiasm for ensuring compliance with regulatory requirements and industry standards as she does for her kids’ athletic careers...which is to say, a lot. Having nearly two decades of industry experience, Gianna specializes in computerized system validation and quality systems. Her current focus is on implementing and validating SaaS solutions for electronic document management and signatures. After work, you can find her leading the cheering section at her kids’ hockey and soccer games.
LEADERSHIP

Donatella Ballerini

Head of eTMF Services
Donatella brings over a decade’s worth of experience to Montrium, where her goal is to find common ground between people, processes and technology, and get the world’s TMF professionals ready for inspection. She is also an active industry leader as a member of the Trail Master File Reference Model Education Governance Committee. Her biggest passion outside of work is having extreme travel experiences, though she admits that she doesn’t trek through deserts or have close encounters with bears since she became a mom.
LEADERSHIP

Gunther Sascha Filkorn

Director of Engineering
Gunther is a Renaissance man like none other. With over two decades of experience in IT and engineering, he currently leads a team of dedicated SaaS technologists as they endeavor to revolutionize clinical trial management and processes. But don’t take our word for it, he will happily talk your ear off about it over a glass of something delicious. Also be prepared to talk about his several interests which span Epicureanism, tinkering, history, politics, and Formula 1.
LEADERSHIP

Luc Bigras

Chief Financial Officer
Luc brings three decades of strategic business expertise to Montrium. Known for building high-performing teams, he specializes in capital allocation among numerous other areas. Luc prides himself on having read one book per week for 25 years, serving as the Honorary Consul of the Republic of Malta, and being a Knight of the Sovereign Military Order of Malta. Despite our best efforts, we can’t convince him to duel. He says he’s not that kind of knight.
LEADERSHIP

Raphael Vergnaud

Director of Sales
Raphael is a seasoned international sales director with a background in software engineering and over two decades of comprehensive experience in diverse markets including Japan, Korea, the UK, and North America. His expertise lies in selling SaaS solutions to enterprises, notably in the life science sector. When he’s not venturing into new markets, he’s traveling around the globe in planes, trains and automobiles. And if the plane has a single engine, you might even see him piloting it.
LEADERSHIP

Stephanie Tanguay

Director of Quality Assurance
For nearly three decades, Stephanie has worn a lot of hats within the life sciences industry. While responsible for Montrium's QMS, she also supports customers in the performance of their due diligence activities by providing insight into company processes and the systems that support them. When she’s not spending time with her sons on the ski slopes, bike trails and golf greens, you can find her experimenting with new recipes in the kitchen.
LEADERSHIP

Charles Fortier

Director of Product
Charles has over two decades’ worth of experience in software and technologies development, having worked in the aviation, amusement, and simulation industries. He is currently focused on working with his team to bring the Montrium ecosystem to the next level. Outside of work, he loves to spend his time...well, outside. You are most likely to find him lakeside enjoying the sights and sounds of nature. We’re not sure about the smells of nature. You can ask him.
LEADERSHIP

Our offices

Montreal

507 Place d’Armes, Suite 1500 Montreal,
QC H2Y 2W8, Canada
+1 514-223-9153

Brussels

Montrium Europe SRL, Boulevard de Waterloo 77,1000 Brussels, Belgium
+32.2.808.3008

Work with us

Our team is growing! Take a look at our open positions.