Tag Archives: Clinical Trial Investment

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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EUROPEAN MEDICAL DEVICE REGULATION – FIVE KEY DRIVERS OF THE PREMARKET CLINICAL EVIDENCE BASE

The Medical Device sector concerns a wide variety of products and the proposed European Medical Device Regulation attempts to regulate the pre- and postmarket clinical evidence base under one umbrella. Driven by scandals such as with the hip and PIP … Continue reading

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DEVICE OR DRUG TRIALS: ARE THEY DIFFERENT?

As previously blogged, it looks like the European medical device regulatory system is heading for a more pharmaceutical like approval system. What are the differences from clinical research perspective and why does that matter? A white paper on that topic … Continue reading

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PUBLISH OR PERISH

Although retractions may sometimes suggest otherwise, publication of clinical data is how to obtain the return on a clinical trial investment. The clinical trial investment is substantial as the process to collect clinical evidence from research sites is involved and … Continue reading

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