A Smarter, More Collaborative Approach to Trial Master File (TMF) Management

At Amarex Clinical Research, we don’t just manage your Electronic Trial Master File (eTMF)—we elevate it. With decades of experience, a proprietary eTMF platform, and a consultative approach, we empower sponsors to take full control of their clinical trial documentation while ensuring global regulatory compliance and real-time visibility.

Why Choose Amarex for eTMF Services?

We’re not just another contract research organization (CRO). We’re your strategic partner in clinical trial success.

Amarex brings over 200 years of combined experience in clinical product development and a proven track record of managing more than 1 million trial records. Our global footprint spans 30+ countries, and our in-house systems are designed to meet the highest standards of GCP compliance, data integrity, and operational efficiency.

What Makes Our eTMF Services Different?

• Proprietary eTMF Platform Built by Amarex: Our in-house eTMF software gives you complete control over your Trial Master File—no third-party limitations, no compromises. Prefer a commercial solution? We also integrate seamlessly with the Florence eTMF platform for added flexibility.
• Global Clinical Trial Expertise: From North America to Asia, we’ve supported 50+ international clinical trials and conducted compliance audits across six continents. We understand the nuances of global regulatory environments, including FDA, EMA, and PMDA requirements.
• Real-Time eTMF Monitoring and Insights: Track study milestones, document health, and site performance in real time. Our advanced dashboards and reporting tools provide actionable insights to keep your trial on track and audit-ready.
• 21 CFR Part 11 Compliant & Secure: Our systems are fully compliant with FDA 21 CFR Part 11, featuring secure eSignatures, audit trails, and document versioning to ensure regulatory readiness and inspection preparedness.
• Remote Collaboration with Clinical Sites: Connect directly with each site’s electronic Investigator Site File (eISF) for seamless document exchange, remote monitoring, and source data verification (SDV)—all within a secure, centralized platform.
• Your Clinical Trial, Elevated: Whether you’re launching a Phase I clinical trial or rescuing a complex Phase III study, Amarex ensures your eTMF is complete, compliant, and inspection-ready—every step of the way.

We don’t just manage documents. We manage outcomes.

Let’s Build a Better Trial Together

Contact us today