Practical guides, methodology notes, and regulatory context for pharma statisticians. Written by Ndoh Penn.
How reproducr scans scripts for silent breaking changes, flags stochastic calls missing set.seed(), detects numerical drift, and generates audit reports for regulated and academic workflows.
How reproducr scans scripts for silent breaking changes, flags stochastic calls missing set.seed(), detects numerical drift, and generates audit reports for regulated and academic workflows.
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How to elicit, document, and justify informative priors for regulatory submissions — aligned with FDA 2026 draft guidance.