Spaces:
Sleeping
Sleeping
| 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. |