Data in pharma
The data that runs pharma, from clinical trials to real-world evidence, and the strict governance (GxP, privacy) that makes pharma data unlike data anywhere else.
Pharmaceutical decision-making rests on data spanning drug discovery, clinical trials, regulatory submissions, manufacturing, and commercial performance. This block builds fluency in the data structures unique to the sector: trial datasets, real-world evidence, pharmacovigilance records, and prescription data feeds. You will examine where this data originates, how its quality is assessed and governed, and which benchmarks analysts use to judge data maturity and reliability. The block then turns to the regulatory and privacy architecture governing patient and clinical data, from GxP frameworks to HIPAA and GDPR, and the audit practices that keep data trustworthy across R&D, regulatory, and commercial functions. The goal is practical command of pharma-specific data literacy, not generic data theory.
Ce que vous allez maîtriser
- Map the core data sources across drug discovery, clinical trials, regulatory filings, and commercial operations
- Evaluate data quality using sector-specific metrics like data completeness, traceability, and audit trail integrity
- Apply key privacy and regulatory frameworks (HIPAA, GDPR, GxP, 21 CFR Part 11) to real pharma data scenarios
- Design and run practical data governance checks and audits for clinical and real-world evidence datasets