Luc Bigras
Chief Financial Officer
Luc Bigras brings over 30 years of strategic finance expertise to his role as CFO at Montrium. His career spans a wide range of industries, from biotech wearables to advertising, giving him a sharp instinct for building financial strategy that supports real business growth. He has deep experience in M&A, capital allocation, and business transformation, having advised and led finance functions for growth companies throughout his career. At Montrium, Luc oversees financing, accounting, legal, and sales and marketing, helping drive the company's expansion as a global SaaS platform serving life sciences organizations across North America, Europe, and Asia.
LEADERSHIP
Michael Zwetkow
Chief Innovation Officer
Michael Zwetkow co-founded Montrium in 2007 and has spent over 20 years helping life sciences organizations use technology to improve their regulated processes. After holding several leadership roles across operations, professional services, and alliances, he now serves as Chief Innovation Officer. At Montrium, Michael focuses on aligning technology vision with business strategy, driving innovation across the organization. His expertise spans GxP regulated systems, computerized system validation, electronic content management, and cloud-based solutions for life sciences.
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
Gianna de Rubertis
Director of Compliance
Gianna has more than two decades of experience in the life sciences industry, specializing in computerized system validation and quality systems. Before joining Montrium, she worked for five years as a validation consultant, giving her a broad view of how life sciences organizations approach compliance challenges. Over her 17 years at Montrium, she has held several leadership roles and now serves as Director of Compliance. Her expertise covers GxP regulatory compliance, 21 CFR Part 11, EU Annex 11, and SaaS validation for pharmaceutical and biotech organizations. Today, Gianna focuses on implementing and validating electronic signature solutions and electronic document management systems, supporting life sciences organizations in their digital transformation while ensuring regulatory compliance.
LEADERSHIP
Gunther Sascha Filkorn
Director of Engineering
Gunther has over 25 years of experience in IT and engineering. As Director of Engineering at Montrium, he leads the team behind eTMF, Reg Docs, and Quality Connect, driving the technical strategy and architecture that life sciences organizations depend on to manage their clinical content. Before joining Montrium, Gunther held senior engineering and product roles at CAE, where he led teams across defence simulation, cloud architecture, and digital product development. That range of experience shapes how he approaches building and scaling the Montrium platform today.
LEADERSHIP
Charles Fortier
Director of Products
Charles brings over 25 years of experience in software and technology development to his role as Director of Products at Montrium. His career spans some of the most demanding industries for technical precision, including aerospace, flight simulation, and amusement technology.
Before joining Montrium, Charles held senior engineering and product leadership roles at CAE, Bombardier Aerospace, and Triotech Amusement, where he built deep expertise in systems engineering, product management, and agile development.
He now leads product strategy at Montrium, working closely with his team to shape the roadmap and advance the Montrium platform that life sciences organizations rely on for clinical content management.
LEADERSHIP
Stephanie Tanguay
Director of Quality Assurance
Stephanie brings nearly 25 years of experience in the life sciences industry to her role as Director of Quality Assurance at Montrium, where she has been a key part of the team for nearly two decades. With a background in both Computer Science and Medical Laboratory Science, Stephanie oversees Montrium's Quality Management System and supports customers through due diligence activities, giving them a clear view of company processes and the systems behind them. Her expertise covers quality assurance, computerized system validation, 21 CFR Part 11, GxP compliance, and SOP development, making her a trusted resource for life sciences organizations working through the regulatory requirements of clinical IT systems.
LEADERSHIP
Paul Carter
Founder, President and CEO
Paul co-founded Montrium in 2005 and has spent over 25 years working on the development, deployment, and validation of computerized systems for regulated clinical trials. He has a strong background in CDISC and ICH standards, as well as in the integration of systems and processes for clinical trials.His work spans major clinical technology projects across North America and Europe, with deep expertise in CDISC and ICH standards and the integration of systems and processes for clinical trials. As President and CEO, Paul leads the overall vision for the Montrium platform. Beyond Montrium, he is Chair of the CDISC TMF Standards Subgroup and a steering committee member of the TMF Reference Model, where he co-leads the development of eTMF Exchange Standards. He is also a regular speaker at industry events and actively contributes to the development of clinical research standards.
LEADERSHIP
