Data in biotech and medtech
R&D and clinical data, device telemetry and real-world performance, quality systems, and regulated data integrity.
Data is the operational backbone of biotech and medtech, spanning clinical trial datasets, genomic and molecular readouts, electronic health records, device telemetry, and adverse event reports. This block equips you to navigate the sector's fragmented data landscape, judge dataset fitness for regulatory and commercial decisions, and apply quality and governance metrics that hold up under FDA, EMA and notified body scrutiny. You will learn which sources matter, how to benchmark data integrity across research and post-market phases, and how privacy regimes like HIPAA and GDPR shape handling of patient and health data. The focus stays strictly on data practice, not general finance, so you build durable sector fluency.
Ce que vous allez maîtriser
- Map and evaluate the key biotech and medtech data sources including clinical, genomic, EHR and device data
- Apply ALCOA+ and other data integrity and quality metrics to trial and post-market datasets
- Design privacy-compliant data handling under HIPAA, GDPR and sector regulation
- Run practical data audits and governance checks aligned to FDA and EMA expectations