Montrium

Compliance-focused clinical and regulatory content platform (eTMF, eQMS, RIM) for lean sponsor, CRO, and service-provider teams.

Montrium, founded in 2005 and headquartered in Montreal, Canada, provides Connect — a platform spanning electronic trial master file, quality management, and regulatory information management — aimed at small and mid-sized sponsors, CROs, and service providers. The company announced its initial SOC 2 certification in 2024. AI-assisted document handling features are recent additions; teams should confirm which capabilities are generally available versus roadmap.

Headquarters
Montreal, Canada
Founded
2005
Compliance
SOC 2 Type II
Deployment options
cloud
Website
https://www.montrium.com
LinkedIn
https://www.linkedin.com/company/montrium

Categories

AI Use Cases

  • Regulatory Submission Authoring

Vendor Scorecard

64% — Partial coverage. Coverage score — how completely Atlas documents Montrium across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.

Compliance & Validation — Documented

SOC 2 Type II

Deployment & Hosting — Documented

cloud

Pricing Transparency — Not documented by Atlas

Ask the vendor: What is your pricing model, and what drives total cost of ownership?

Implementation & Onboarding — Not documented by Atlas

Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?

Organization & Role Fit — Documented

Biotech Startup, Mid-Size Biotech, CRO / CDMO, Regulatory Affairs, Clinical Operations

Solution Scope — Documented

Regulatory Submission Authoring

Company Viability — Partially documented

Private, Founded 2005

Always ask the vendor

Not captured in Atlas data — confirm directly. Excluded from the score above.

Data Rights & IP

Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?

Model Credibility & Explainability

Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?

Questions to Ask This Vendor

  • Which modules (eTMF, eQMS, RIM) are strongest for organizations our size?
  • What is the current scope of the SOC 2 report, and is a Type II audit complete?
  • Which AI-assisted features are in production today?
  • How is inspection readiness supported when auditors request TMF access?