When compliance isn’t enough: when is a clinical study truly safe?
Many clinical studies begin with a reassuring sense of security: the protocol is approved, the documentation is complete, regulatory requirements are met. Yet anyone who actually works in clinical research knows this: initial compliance is not the same as safety. The real question is not whether a study is compliant today, it is what happens…
PMS and Real-World Data: when real evidence begins after the study
When a clinical study changes its nature For a long time, post-market was treated as a phase that comes after the study.A necessary surveillance activity, but separate from clinical research itself. Today, that approach no longer works. Medical devices, especially digital and connected ones, continue to generate data long after the last patient visit.And that…
