10 · Healthcare & Life Sciences
Clinical Research & Evidence
Clinical evidence cannot be improvised at submission: it is designed from the research question onwards, with the protocol and data management compliant from the start.
We handle study design and clinical evaluation with our MedTech advisor; contracts and data are handled by the Firm.
Our services
The issues we address
Clinical evaluation plan and report, and PMCF plan (Regulation (EU) 2017/745, Art. 61 and Annex XIV).
Design of clinical investigations: endpoints and sample size (MDR Articles 62–82; ISO 14155).
Ethics Committee submissions and notifications: protocol, informed consent, DPIA.
Legal bases for health data in research and its secondary use (GDPR, Articles 9 and 89).
The system, in motion
How we work, phase by phase
A continuous cycle, not a one-off intervention. Select a phase to see what it involves.
The method
Clinical Evidence
Research question
We start from what needs to be demonstrated, and to whom: Notified Body, Ethics Committee, funder or health service.
Let's look at your case
A 20-minute call with the person who handles it, in plain language.