Tag Archives: Monitoring

2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS

  Nothing could have been more illustrative for the medical device clinical trial environment in Europe  than the storms Ciara and Dennis in February. With BREXIT as a kick off, the Coronavirus spreading around te globe, the MDR deadline less … Continue reading

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INFORMED CONSENT – 5 CRITICAL ELEMENTS TO MONITOR

Ensuring proper informed consent in clinical studies is a critical process, that protects the rights, safety, and welfare of human subjects involved. It will require even more attention under the new GDPR and with the globalization of clinical trials. Although … Continue reading

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THE ON-SITE MONITOR: A SPECIES NEARING EXTINCTION?

Site monitoring represents minimally 15% of your total clinical study budget, and concerns an expense that benefits enormously from digitization and evolving regulatory insights: Electronic data capture and querying, online study training, remote monitoring, and risk-based monitoring, and makes you wonder whether it … Continue reading

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FOUR (NOT) TO DO’S TO PREVENT PAPER WITHDRAWAL

The vote regarding the proposed Medical Device Regulation is once more postponed, so we will need some more patience before knowing where we are heading in Europe with the Medical Device Directive. One thing, however, speaks clearly from the proposal … Continue reading

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