In early phase clinical development, medical monitors (MMs) are essential for ensuring participant safety, reliable data collection, trial integrity, and regulatory compliance. However, not every study requires a full-time MM, with many sponsors often relying on their principal investigators (PIs) to provide oversight in healthy volunteer and first-in-human studies. Increasingly, a hybrid approach – combining PI-led monitoring with external expertise – offers the flexibility and responsiveness these trials demand.
The Value of a Hybrid Approach to Medical Monitoring in Early Phase Clinical Development
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