Consulting
Scientific expertise for regulatory engagements, study design, and more.
Expert guidance, every step of the way
When your evidence needs to be rigorous, defensible, and ready for regulatory review, our consulting team is here to support you.
Led by internationally recognized experts — including leaders ranked in the world’s top 2% of most-cited scientists — we provide practical guidance across study design, strategy, and regulatory engagements to ensure your evidence generation is robust, valid, and actionable.
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Explore our expert consulting services
RWE consulting
Expert guidance for regulatory engagements and RWD study design, led by recognized industry leaders.
RWE research
Expert support from study design to dissemination to generate trusted evidence. Consultation to strengthen your evidence strategies and improve research outcomes from leaders in the field.
External control arms
Generate representative, fit-for-purpose control data with TriNetX external control arms.
Epidemiological services
Our epidemiological consulting team brings decades of experience to advance your goals through every stage of the evidence generation journey.
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Got a question, query, or just want to learn more? Our RWD experts are a click away
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Explore our latest articles, news, and whitepapers
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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