Medical device companies are facing more challenges than ever. A changing regulatory landscape makes bringing devices and diagnostics to market difficult; planning missteps cost you time and money. Each day Novella Clinical helps device, diagnostic and drug/device combination sponsors navigate regulatory hurdles and provides guidance from regulatory assessments to post-marketing strategies.
But perhaps the most satisfying work lies in between – designing and executing clinical trials. As one of the largest CROs supporting medical device sponsors, Novella has the global footprint and clinical depth to expertly guide you through the clinical trial process, resulting in the clinical data critical to moving your product forward.
And for over a decade we have been helping sponsors do just that – bring products to those who need them. Although our clinical experience is all-inclusive, our therapeutic concentrations for device and diagnostics include cardio/vascular, orthopedic/spine, general surgery and oncology.
Novella is proud to have earned preferred vendor status with two of the top five medical device companies due to our outstanding operational execution, quality management program including ISO 9001:2008 certification, and superior client satisfaction ratings.