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.
What you'll master
- 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
Key terms
Modules
Applies core data practices to clinical trials, device telemetry, and quality analytics in the sector.
Covers the sector data landscape, sourcing, quality metrics, and measurement standards.
Covers health data regulations, de-identification, consent governance, and pre-inspection audits.
Latest articles
Recent articles from the blog that apply to Biotech & MedTech.
- One HCP, six records: why identity resolution is pharma's most expensive data problemA single cardiologist can exist as six different entities across a pharma company's CRM, claims data, and prescriber analytics systems, and none of them match. Until identity resolution works in practice, every downstream decision, from sampling allocations to pharmacovigilance reporting, is built on a fractured foundation.
- GxP integrity, 21 CFR Part 11, and GDPR: what happens when three regulatory regimes collidePharma CDOs operate at the intersection of three distinct regulatory systems, each with its own logic, its own enforcement body, and its own definition of what a data record actually is. Understanding where those systems conflict, not just where they overlap, is the difference between audit readiness and a consent notice architecture that accidentally destroys your audit trail.