If you work in clinical trials and have anything to do with patient-reported outcomes (PROs), there’s one book you simply need on your shelf:
Electronic Patient-Reported Outcome Measures: An Implementation Handbook for Clinical Research (Second Edition) by Willie Muehlhausen, founder of Safira Clinical Research, and co-author Bill Byrom.
This isn’t just a reference guide. It’s the book on ePRO implementation—an industry gold standard that bridges science, technology, and practical execution.
Why This Book Matters
Since the first edition launched in 2018, this handbook has become essential reading across the pharmaceutical and research industries. The newly released second edition builds on that foundation, incorporating:
- The latest regulatory guidance
- Insights from ISPOR task force reports
- Lessons from real-world eCOA Masterclass workshops
- Updated best practices for design, validation, and global implementation
Whether you’re new to ePRO or a seasoned expert, this edition walks you through the why and how of electronic patient-reported outcome measures. It covers everything from device selection and BYOD strategy to cultural considerations and user acceptance testing pitfalls.
You’ll find real-world recommendations, like how to reduce missing data, manage branching logic, and avoid costly mistakes in implementation. It even addresses common practical questions like:
“Should patients be allowed to skip items?”
“What happens if data is entered late?”
Who Should Read It?
- Clinical operations professionals looking to improve trial data quality
- Sponsors and CROs seeking faster, cleaner ePRO builds
- Tech vendors and designers building patient-friendly apps
- Regulatory and quality experts working to meet ALCOA+ requirements
- Anyone tasked with eCOA, ePRO, or BYOD strategy in trials
If you touch any part of the ePRO lifecycle, this book will make your work more efficient, more compliant, and ultimately more patient-centered.
More Than Just a Handbook—A Way to Give Back
In true Safira spirit, all royalties from this book are donated to two meaningful charities:
- StoneBridge City Farm (Nottingham, UK) – supporting adults with learning difficulties
- UNICEF’s Emergency Ukraine Appeal – helping children and families impacted by conflict
When you buy this book, you’re not only investing in better clinical trial outcomes—you’re supporting real people around the world.
Get Your Copy Today
Whether you’re launching your first ePRO system or refining your tenth, this handbook is your go-to reference for doing it right. It’s concise, accessible, and—according to industry leaders—essential.
📘 Available now on Amazon
