About
Dr Luke Koschalka
Clinical Psychologist (ClinPsyD) and Neuroscience Clinical Development Strategist with over 20 years’ experience across global Phase I–III CNS trials.
Sponsor & CRO Perspective
I am a UK-trained Clinical Psychologist with extensive experience in global neuroscience clinical development across both sponsor and CRO environments. This dual perspective shapes how I support programs — not only what the data needs to show, but how to operationalise that standard across complex, multi-regional trials.
I support biotech sponsors and CROs in designing, optimising, and governing neuroscience development programs — from early-phase strategy through pivotal studies.
My focus
Delivering high-integrity data while reducing development risk and timeline delays in complex central nervous system trials.
20+
Phase I–III trials with scientific oversight
5
Regions delivered: EU, UK, NA, APAC, LATAM
10+
CNS indications across Neurodegenerative, Psychiatry & Rare Disease
My Approach
Four Principles. One Goal.
Programs that are both scientifically robust and operationally deliverable.
Clinical Insight
Direct clinical perspective on patient experience and assessment.
Scientific Rigour
Evidence-driven endpoints, methodology, and signal detection.
Operational Realism
Designs that work at site level, not just in protocol.
Strategic Risk Awareness
Anticipating issues before they become program threats.
Let’s talk about your program
A short conversation often reveals where the biggest leverage sits.