Practical guides, methodology notes, and regulatory context for pharma statisticians. Written by Ndoh Penn.
How to run the pre-written IQ/OQ/PQ protocols, capture the qualification record, and log the qualification process itself — for 21 CFR Part 11 and EU Annex 11 regulated environments.
How to run the pre-written IQ/OQ/PQ protocols, capture the qualification record, and log the qualification process itself — for 21 CFR Part 11 and EU Annex 11 environments.
End-to-end audit logging for a Phase III RSV vaccine trial — GMT computation, seroconversion rates, outlier review, electronic sign-off, and hash chain verification.
Building ADEFF from ADSL and ADLB with row-level provenance — population flags, change from baseline, EASI-75 responder flag, CONSORT table, and subject-level tracing.
New-user active comparator cohort derivation from administrative claims — every exclusion criterion documented, every patient traceable, CONSORT table automatic.
TEAE summaries, SAE flagging, safety signal documentation, dual electronic sign-off, and submission-ready audit trail for a Phase III NSCLC trial.
How to elicit, document, and justify informative priors for regulatory submissions — aligned with FDA 2026 draft guidance.