Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President
Data integrity in clinical trials refers to the completeness, accuracy, and reliability of trial data throughout its lifecycle. If you read our previous blog “Regulatory Approval Top Red Flag: The Rise of Data Integrity Warning Letters” , you know data integrity is now the #1 reason for regulatory warning letters. But why is this happening?
The answer, in short: trials are getting way more complicated. And regulators have taken notice. In recent years, the FDA and EMA have been sounding the alarm, linking the surge in data integrity issues directly to this rising complexity.
A Decade+ Shift: From Simplicity to Complexity
Data Overload
Back in the day, collecting a few thousand data points in a trial was normal. Today? A typical Phase III study can generate 3.6 million data points. That’s a lot to track, clean, and verify.
Endpoints Galore
Protocols now chase more outcomes. The number of endpoints has doubled within a decade thanks to the rise of exploratory and “nice-to-have” measures. More endpoints = more complexity.
Procedures Per Patient
Phase III protocols used to involve about 130 procedures per patient. That number shot up to nearly 270 within a decade — over 100% increase in patient burden and logistical complexity.
Going Global (Geographic Spread)
Trials are everywhere—literally. The average Phase III study now spans 14 countries, and some involve 30+. That global scale introduces challenges in communication, oversight, and data consistency.
Investigators/Sites Per Trial
Phase III trials now run across 80–90 sites, up from ~40 a decade ago. But many of these sites enroll few (or zero!) patients—adding cost and complexity without much value.
The Rise of New Data Sources
Remember when EDC and labs were the only players in town? Now we’ve got wearables, ePRO, mobile apps, imaging, remote sensors, and more. Today, over 82% of the Phase III studies use such these new data sources with only 30% of trial data comes from traditional eCRFs.
Complexity = Risk
This isn’t just about data volume. It’s about fragmentation, noise, and the increasing difficulty of ensuring data quality, traceability, and reliability. Regulators are watching closely—and they expect sponsors to be in control of their data, no matter how complex the trial.
The Bottom Line
The complexity of today’s trials is a major driver behind the rise in data integrity warning letters. And if your data can’t stand up to inspection, your submission could be delayed—or worse.
But there’s good news…
Coming Up Next
In Part 3 of this series, we’ll show you how continuous, proactive data monitoring can help you stay ahead of issues and avoid the scramble at submission time. With the right approach, managing complexity—and protecting your submission—can be simpler than you think.
Stay tuned.
About the Author
Eyal has over 25 years of experience transforming clinical data into actionable insights. With a B.Sc. in computer science, he began in software development before moving into clinical informatics at Millennium Pharmaceuticals (Takeda Oncology), where he led data management and analysis initiatives. His background spans clinical development, regulatory, QA, and LIMS, with a strong focus on data standardization and CDISC-based solutions.
In 2009, Eyal co-founded Bioforum, a leading Biometrics CRO with over 200 employees and more than 100 active customers worldwide. At Bioforum, he specializes in data management, statistical programming, biostatistics, and medical writing—helping pharma and biotech companies harness the full potential of their clinical data. He is also the co-founder of BionData, creator of JetConvert, which automates SDTM conversion to streamline clinical data workflows.
New Workshop: Is Your Clinical Data Ready for Submission?
This customized in-house workshop, led by Eyal Wultz—Co-founder of Bioforum and BionData—equips sponsors and trial teams with the tools they need to ensure their clinical data is complete, traceable, and ready for regulatory submission. Tailored to your team’s real-world challenges, the session offers practical guidance drawn from over 25 years of experience in clinical research and data strategy.
Ready to get your data submission-ready?
Learn more about the workshop.
Resources
Clinical Trials with Decentralized Elements and GCP Inspections
Protocol Design and Performance Benchmarks (PubMed)
TUFTS CDD IMPACT Report Volume 25 Number 3 May 2023
Building Patient-Centric Trials Putting the Patient First (CISCRP)
Technology Adoption in Clinical Trials: Trends & Plateaus in 2023
Modernizing Data Management in the D-Clinical Age