Areas of expertise

What we do

Strategic advisory

  • Clinical AI design — bringing clinical trial expertise into AI products, from concept to regulatory validation
  • Trial design — adaptive, Bayesian, and estimand-driven strategies for complex development programs
  • Regulatory strategy — aligning statistical methodology with FDA and EMA expectations from the start
R (Shiny · RMarkdown · gsDesign · rpact) Python (statsmodels · lifelines · scipy) SAS ICH E9

Operational support

  • Full-embedded statistical support across Phase I–III programs
  • SAP authorship, programming oversight, and study-level reporting
  • CDISC-compliant datasets, TLF production, and submission-ready packages
Python (scikit-learn · XGBoost · pandas · NumPy · SHAP) Deep Learning NLP SQL