Dummy Data Just Got Really Smart
From hand-typed test patients to learned, coherent simulation — what changed, and why now.
The CORE Rules Engine: Fulfilling the Promise
From founding the SDS Conformance Rules team to CORE-in-the-loop today — an insider's arc.
Rehearse the Study: Test Data Before First Patient In
PASS twins, FAIL twins, and edit-check UAT that runs itself.
Why Humans-in-the-Loop Still Matter
Agents propose, people decide — adjudication as a feature, not a compromise.
Advanced Code Generation: AI's Role and Responsibility
Generated SAS, R, and Python that is executed and verified — not just emitted — and where accountability sits.
How Biomedical Concept Evolution Challenges Implementation
Concept and specialization churn versus frozen study builds — keeping a catalog current without breaking studies.
Synthetic Data, Then and Now: Revisiting My 2019 Interchange Paper
Advocacy before the wave — what held up, and what the field still gets wrong.