Clinical Data Management and Clinical Data Science A Practical Approach
summary
Company builds an integrated EHR/EDC platform (beta at Switzerland’s largest hospital) that captures 5–10,000-question forms, links wearables and SmartWatches, enforces MedDRA and WHODrug coding, and produces regulated SDTM/ADaM exports. Workflows handle trials lasting years (example at year four), scale to millions to billions of data points, and run metadata analytics for real-time risk-based monitoring that flags site delays, protocol deviations (one study shows ~1 in 2 patients with deviations in Bulgaria) and can save sponsors millions by targeted intervention.
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chapters (15)
- 0:00Introduction
- 0:24Talk overview
- 1:10Data roles
- 3:22Electronic data capture and wearable integration
- 5:10Data management lifecycle
- 6:38Patient-centric trials
- 8:03Protocol and endpoints
- 10:35Patient flow
- 12:41Standardization and compliance
- 14:29Data quality and audits
- 15:57Real-time monitoring
- 18:03Risk-based analytics
- 20:12Regulatory submission
- 23:41Statistical reports
- 24:51Question and answer session
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