External Control Arms
Build smarter control groups with fit-for-purpose real-world patient cohorts.
Shorter timelines. Stronger evidence.
Based on a proven methodology built upon 30+ years of experience, TriNetX external control arms (ECAs) help you with timely, representative, granular, and fit-for-purpose control groups.
Designed for studies where randomized controls are impractical, our experts will guide you through set-up, regulations, and execution as we use real-world patient data in lieu of additional patient recruitment, reducing costs and timelines while generating robust, regulation-ready evidence to support your trial.
Navigate regulatory uncertainty with confidence
Strengthen your HTA and EMA submissions with representative, fit-for-purpose ECAs designed for regulatory readiness.
Our methodology ensures scientifically sound data and processes, delivering evidence that regulators can trust and increasing your chances of a successful submission.
Overcome data and implementation challenges
TriNetX ECAs maintain the integrity of your analyses and results while helping you gain deeper insights into treatment impact. You can even generate supplementary control information for prospective experimental arms.
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Explore our insights
Big data isn’t always the right data. Learn how to assess whether a dataset is truly fit for your research question, because data fitness is about the right elements for the right cohort, not dataset size or reputation.
EHR data is one of the richest sources for real-world research, but it was never actually designed for it. This video covers the opportunities, the pitfalls, and the mindset needed to get the most out of it.
Misaligned definitions don’t just complicate analysis; they produce misleading results. Learn why harmonized definitions are essential for multi-site RWD studies and what it takes to make them stand up to scientific and regulatory scrutiny.
At ISPOR 2026, we presented posters addressing outcomes in relapsed/refractory DLBCL, and introducing a reproducible method for generating population estimates robust enough to stand up in HTA and regulatory submissions.
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