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🔧 MasterControl Clinical Excellence

MasterControl Clinical Excellence

Connecting quality throughout the product life cycle.

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Overview

MasterControl's clinical solution extends its well-established Quality Management System (QMS) to the clinical trial space. It focuses on ensuring quality and compliance throughout the trial, integrating document management (eTMF), training records, and quality event management (CAPA, deviations) with clinical trial oversight.

✨ Key Features

  • eTMF Management
  • Site Management & Monitoring
  • Integrated Quality Management (CAPA, Deviation, Training)
  • Document Control & SOP Management
  • Audit Management
  • Risk Management

🎯 Key Differentiators

  • Native integration with a comprehensive Quality Management System.
  • Strong focus on compliance and document control.
  • Manages the entire product lifecycle from clinical to manufacturing.

Unique Value: Provides a single source of truth for both clinical trial management and quality management, breaking down silos and ensuring compliance across the product lifecycle.

🎯 Use Cases (3)

Organizations that want to tightly integrate their clinical operations with their quality management system. Managing TMF documents and quality events in a single system. Ensuring GxP compliance across clinical and quality processes.

✅ Best For

  • Medical device and pharmaceutical companies with a strong focus on quality management.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Organizations looking for a standalone, lightweight CTMS for operational tracking without deep QMS integration.

🏆 Alternatives

Veeva Vault CTMS Oracle Clinical One

Offers much deeper, native QMS functionality than other CTMS providers who may only offer light quality features or integrations.

💻 Platforms

Web

🔌 Integrations

Other MasterControl QMS modules

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (All tier)

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ ISO 9001 ✓ ISO 13485

💰 Pricing

Contact for pricing
Visit MasterControl Clinical Excellence Website →