The simplest life science content management software

Clinical, Quality, and Regulatory content management systems built for scaling life science teams, who don’t have time for findings.

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Trusted by life science teams worldwide

Zydus logo
Siron Clinical logo
SignalChem LifeSciences
Pharmascience logo
Orphazyme logo
Oncobay logo
Obviohealth logo
MAPS Public Benefit Corporation logo
InforRLife logo
Immune Biosolutions logo
Illingworth  logo
HungaroTrial CRO logo
EpicentRx logo
Entos Pharmaceuticals logo
Easthorn logo
Criterium logo
Ambel Biosolutions logo

Designed by people who know GxP compliance firsthand

Developed by CRO and biopharma veterans, we know what inspectors look for, and we build our solutions to deliver it. In a market full of software vendors, we strive to support you as the most expert, most human team in e-clinical tech. We make your compliance our business.

Clinical trial compliance software and services for every team

Life science content management tech that helps small sponsors and CROs win big. 

eTMF Connect logo

Tell a clear clinical trial story that inspectors can follow

Centralize every study record into one compliant hub, giving inspectors a complete, coherent view of your study — and your team the time back to focus on what actually matters to move the study forward.

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eQMS Quality Connect logo

Manage your entire quality system in one place

Bring document control, training oversight, and quality event management into one place, with the automated workflows to make sure nothing slips through the cracks.

Illustration of a purple document window with comment boxes and three diverse people’s faces around it, representing collaboration.
RegDocs Connect logo

Stop coordinating, start submitting

Centralize your entire regulatory operation, from submission planning to health authority correspondence, so lean teams move faster and never lose sight of what's holding things up.

Two workers looking at their RegDocs Connect dashboards
Adobe Acrobat Sign Validation Services

Get — and stay — 21 CFR part 11 compliant

Ensure continuous validation of your e-signatures with every major Adobe Acrobat Sign Update. Montrium’s validation services perform the leg work, while you get the compliance stamp of approval from inspectors.

A person signing a signature with the Adobe Acrobat Sign Validation
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 photo
Magali Lurquin
Senior Associate, Regulatory Affairs
“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 headshot
Margaret Farrell
Director of Quality Assurance
ObvioHealth logo

Technology gets you started. Support keeps you going.

With 11,000+ users in our system, we take support seriously. Our team knows regulated environments inside out, and we're here when things get tricky, so you don’t have to slow down.
96.2%
customer support satisfaction
98.5%
of all tickets are solved  
45%
tickets solved in under 24 hours
3 hours
first time reply average

Built for the teams running today’s clinical trials

From non-profits to BioPharma, Montrium gives scaling life sciences teams the confidence to know that their clinical, quality, and regulatory documentation are exactly where they need to be at the moment everything is on the line.

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Nonprofit

Nonprofits drive some of the most important clinical research in the world — your technology should reflect that.
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Medical device

Medical device and diagnostic manufacturers face a constantly evolving regulatory landscape, and you need tools that evolve with it. 
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Pharma / Biotech

Scaling biotech and pharma teams move fast and drive real innovation. They deserve enterprise-grade tools built for the way smaller organizations actually work.
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CRO

As sponsor expectations rise, CROs need the document and quality management capabilities to meet the bar. 

Speak with a product specialist

Tell us where your team is today and we'll show you what Montrium looks like for your specific situation.

Frequently asked questions

Find answers about Montrium product and services, implementation, and how it works for your organization.

Where is customer data hosted?
How long does implementation take?
What support is included after go-live?
Is Montrium's software validated for GxP environments?