Most CNS trials don’t fail because the therapy doesn’t work. They fail because assessment variability buries the signal.
This white paper explores how linguistic and cultural adaptation, lifecycle rater training and modern eCOA technologies can work together within a unified endpoint quality framework in neuroscience clinical trials.
By connecting these activities across the endpoint lifecycle, sponsors can reduce avoidable measurement variability, strengthen oversight and ultimately protect the treatment signal from study start through database lock.
In CNS trials, treatment effects can be difficult to detect not because therapies lack potential, but because disease complexity and assessment variability can obscure the signal.
Estelle Haenel · Dan Herron
CMO @Kayentis · Global VP Digital Health @RWS Group
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Scales like ADAS-Cog, MADRS, and PANSS depend on human judgment. When raters vary, the signal degrades regardless of any treatment effect.
Six stages covering qualification through remediation, designed to maintain consistency as sites change, protocols evolve, and staff turns over.
Certified-rater access controls, structured ClinRO administration, real-time edit checks: how technology enforces consistency at the point of assessment.
What to have in place before FPI, during study conduct, when issues arise, and before database lock.
Estelle Haenel joined Kayentis as Chief Medical Officer in 2019. She has 25+ years of experience in pre-clinical and clinical research in Top 5 Pharma and Biotech companies. A Doctor of Pharmacy, Estelle also has Masters in Endocrinology and Cellular Interaction and a PhD in Biochemistry and Molecular Biology.
Dan Herron is Global VP, Digital Health at RWS Group, where he leads global Linguistic Validation operations, commercial strategy and business strategy, with responsibility across clinical outcome assessments, rater training and digital health solutions. He works with pharmaceutical, biotechnology and clinical technology organizations to strengthen how clinical outcomes are translated, implemented and measured globally, improving the consistency, quality and scalability of clinical trial data.
Download the paper and see how rater training and eCOA, used together, reduce the variability that costs CNS trials their results.
