How Much ROI Can You Expect from eTMF and CTMS? 

July 31, 2025

A Comparative Look at Europe vs. US Markets 

In clinical operations, time is money – but how much money can technology really save you?

We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, error mitigation, and improved oversight, we show how these tools perform financially in Europe and the United States – with their respective labor costs. 

Hourly Rate Assumptions 

To reflect regional labor costs, we used: 

• €50/hour for Europe 
• $90/hour (≈ €83) for the US 

These hourly rates dramatically shape the cost savings, especially in tools that reduce repetitive work like document management, trial monitoring, and study management. 

What We Analyzed 

The analysis covers five core areas of savings:
1. Personnel efficiency: fewer hours spent on redundant tasks
2. Duplicate document elimination
3. Regulatory compliance gains
4. Document management productivity
5. Trial oversight and operations savings 

Conditions assumptions: 

• 296 documents in eTMF and 160 documents in CTMS 
• 8 hours a year spent in total per document without a system in place and twice less with eTMF and CTMS  
• 20 studies total 
• 25-30% efficacy improvement with the system in place  
• Initial costs for purchasing Flex Databases System and the following years subscription fees

ROI Results in a 5-year perspective: eTMF and CTMS in EU and the US 

Key Takeaways: 

eTMF leads in ROI, with over 10× return in both markets. Its impact is concentrated on document management and compliance. Big number of documents also influences the results.

CTMS has larger absolute savings, thanks to operational efficiencies across multiple modules.
The US sees higher ROI due to elevated hourly wages and our system pricing being European level. Every hour saved is worth more – making automation even more financially compelling. 

Why It Matters 

Too often, ROI for digital tools in clinical trials is presented only in vague terms like “efficiency” or “quality.” But this analysis translates those gains directly into euros and dollars – helping clinical operations leaders, CFOs, and procurement teams justify investment decisions.

When a tool can return 7–11 times what you spend on it, the financial argument becomes hard to ignore. 

Final Thought 

Whether you’re operating in Europe or the US, the numbers show that investing in eTMF and CTMS isn’t just about modernization – it’s a strategic financial decision.

Marietta Sarkisyan is the Global Director of Business Development and Marketing at Flex Databases. She has over 13 years of experience in clinical trials industry. Marietta has held roles in both operations and business development across global markets. She brings a strong understanding of clinical research and a strategic approach to delivering tech-driven solutions.