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Montrium

Regulated Content and Quality Management for Life Sciences.

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Overview

Montrium provides a suite of cloud-based solutions for life sciences organizations to manage regulated content and quality processes. Their products include eTMF Connect for managing trial master files, and Quality Connect for managing quality documentation and processes, all built on a compliant GxP platform.

✨ Key Features

  • eTMF Connect (Electronic Trial Master File)
  • Quality Connect (QMS)
  • Regulated Content Management
  • Document Control & Collaboration
  • Training Management
  • GxP Compliant Platform

🎯 Key Differentiators

  • Focus on emerging and mid-sized life sciences companies
  • Integrated eTMF and QMS on a single platform
  • Emphasis on customer support and partnership

Unique Value: Provides an integrated and intuitive platform for managing both clinical trial documentation (eTMF) and quality systems (QMS), helping growing life sciences companies scale their compliance efforts efficiently.

🎯 Use Cases (4)

Managing the Trial Master File for sponsors and CROs Controlling quality documents and SOPs Collaborating on regulated content with external partners Maintaining inspection readiness of TMF and QMS

✅ Best For

  • Used by emerging biotech and pharma companies to establish compliant TMF and quality systems.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Research sites needing an eISF (their focus is sponsor/CRO eTMF)
  • Companies needing a full CTMS or EDC solution

🏆 Alternatives

Veeva Vault eTMF Phlexglobal SimpleTrials

Offers a more modern and integrated eTMF/QMS experience than disparate systems, and is more accessible for emerging companies than large-scale enterprise platforms.

💻 Platforms

Web API

🔌 Integrations

Microsoft Office 365 Veeva Vault API

🛟 Support Options

  • ✓ Email Support
  • ✓ Live Chat
  • ✓ Phone Support
  • ✓ Dedicated Support (Enterprise tier)

🔒 Compliance & Security

✓ SOC 2 ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ EU Annex 11 ✓ GxP

💰 Pricing

Contact for pricing

✓ 14-day free trial

Free tier: N/A

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