The scope of CDM is no longer limited to Electronic Data Capture (EDC) systems. Clinical trials now involve
data from wearables, sensors, imaging, genomics, real-world data (RWD), and eCOA. To manage this,
professionals must address the “5Vs” of data:
- Volume: large and growing datasets, sometimes billions of points per patient.
- Variety: structured and unstructured data from many sources.
- Velocity: near real-time or continuous data streams.
- Veracity: ensuring reliability and accuracy with risk-based review.
- Value: using data not only for regulatory submissions but also for insights, synthetic arms, and machine learning.
Platforms must enable interoperability (APIs, cloud), automation, and secondary data uses to support
modern trial designs.