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 is precisely where the real test of robustness begins.
The question is no longer:
“Did the study go well?”
But:
“Are we able to govern what happens after?”
Post-Market Surveillance is no longer a formality
Today, PMS is no longer:
- a passive collection of reports
- a periodic document to produce
It has become a process that is:
- continuous
- structured
- integrated into the entire lifecycle of the device
This radically changes how clinical studies must be designed.
Because evidence is no longer something you “close” at the end of the trial.
It becomes something you must sustain over time.
The real challenge: real-world data
Real-world data holds enormous value.
But without method, it can quickly become a problem instead of a resource, because signals are rarely clear-cut, populations are heterogeneous and usage contexts are highly variable
Without defined criteria:
- irrelevant signals can be overestimated
- emerging risks can be underestimated
The difference is not made by the amount of data collected.
It is made by the ability to interpret it clinically and strategically.
Governing the path from RWD to decision
An effective PMS does not start with more data.
It starts with better governance.
It requires:
- a clear definition of what constitutes a relevant signal
- structured risk assessment criteria
- escalation processes that are defined in advance
- documentation that is coherent and defensible over time
This is where a CRO truly makes the difference: not by collecting more data, but by governing the data that already exists in a way that protects decisions.
The role of a CRO in modern Post-Market
Today, a reliable CRO does more than execute surveillance activities.
It helps structure PMS already during the study design phase, it ensures coherence between pre-market and post-market evidence, and protects both sponsor and device over time
Because real evidence does not end with the last patient. It begins when the device enters real life.
Evidence today is a lifecycle responsibility
The value of a clinical study today is not measured only by its final results.
It is measured by its ability to support the device over time, and that requires method and vision. If post-market is treated as a regulatory obligation, it becomes a risk.
If it is treated as part of the lifecycle, it becomes a guarantee.
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