Technical articles
Technical articles
16/11/2021
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF/PMPF) and PMCF/PMPF Studies
Post-Market SurveillanceFor any MD (including IVDMDs) placed on the market, made available on the market or put into service, manu
Technical articles
27/07/2021
Data Integrity – The adventures continues
Why data integrity?Data are central to all our interactions, communications and strategic decision-making. In the pharmaceutical a
Technical articles
20/02/2020
Validation of analytical procedures according to the ICH guidelines
Since 1990, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has been
Technical articles
4/02/2020
New trends in medical journals: limited use of p-values in favour of estimated indicators and confidence intervals
Why is the p-value, once so widely used, now being called into question?
Technical articles
27/11/2019
Clinical investigation: which type for which need?
The application of the European regulation regarding medical devices is fast approaching, and many manufacturers will have to brin
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