Article | March 12, 2016

Medical Device Trial Integration: Eliminate Device Study Risk

Source: Cenduit LLC

Cardio devices. Spine breakthroughs. Knee advancements. Each medical device is highly unique and the same is true of every device trial. Technology advancements are novel and innovative, and study parameters vary widely. What’s more, device study groups tend to be smaller than drug trial groups, yet patient unpredictability is common. And many device studies are challenging to blind, randomize, and control. Consider in-trial device modifications, ever-changing FDA regulations, unique patient challenges like device sizing, and diverse physician techniques, and you’ve got a challenging study on your hands.

Insight and innovation make the difference Our insight into different regulatory implications, combined with our IRT expertise and innovation, can take your trial to the next level.

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