ich-guidelines

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itsAtifMalik / clinical-data-management-project-LFTs-in-covid19

A prospective registry assessing hepatic enzyme derangements and inpatient outcomes in hospitalized COVID-19 patients; features GCP and 21 CFR Part 11-compliant eCRF design, data dictionary, and validation workflows.

gcp clinical-trials observational-study redcap biomarkers edc liver-disease clinical-data-management observational-data cdisc-odm 21-cfr-part-11 ich-guidelines ich-gcp

Updated Sep 25, 2026

ahmedn12 / cmc-stability-analyzer

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ICH Q1E shelf-life prediction from accelerated stability data · Python · pandas · scipy · plotly

python data-science cmc stability-analysis pharmaceutical-sciences ich-guidelines

Updated May 17, 2026
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repro-stats / repro-stats.github.io

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Open-source R packages for reproducible, regulation-ready pharmaceutical data science

r statistics clinical-trials bayesian reproducibility pharma regulatory 21-cfr-part-11 ich-guidelines

Updated Oct 14, 2026
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