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Device Risk Based Monitoring

A focus from 2016 was on the new area of Risk Mitigation in medical device trials. A hot topic in the pharma world, increasing numbers of medical device companies are looking into how they can utilise the approach to save money and time on their operations.

The sessions focussed on how companies of all sizes can look to make the move towards risk based monitoring for their trials, with case study examples being delivered by St Jude Medical – a forerunner in this area within North America.

There was also a more specific focus on how companies can manage the endpoints of their study. A specific focus on trial design from Axonics Modulation Technologies, Inc. highlighted how trial sponsors can get more from their trials by gathering and utilising various endpoints .

In addition to this, roundtables at the end of the second day proved great opportunities for experts to gather and discuss key issues such as blinded trials and key global locations for clinical trials.





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