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Showcasing unique examples of the successes we’ve had with clients who used our process-oriented clinical study approach.
A medical device company’s post-approval study launch had been stalled for so long that continued FDA approval for their product was at risk. Furthermore, the company’s planned post-approval study, which aimed to monitor the long–term safety of their medical device, required a lengthy, five-year follow-up – and thus a large consumption of resources. Bright was brought in to help.
Opting for a rare clinical event endpoint meant that a medical device company’s proposed clinical trial would require thousands of subjects and a years-long enrollment period. Options were limited as all prior device studies in this therapeutic space had used this same rare endpoint, too.
A medical device company developed a brilliant solution for a rare but life-threatening situation that could be encountered during standard percutaneous coronary interventions (PCIs). Due to the complexity of PCIs and the infrequent but very serious nature of the clinical situation where this device would be needed, gathering data on device safety and efficacy was going to be difficult. With the FDA requiring a robust, prospective clinical trial, the client needed to figure out a way to overcome this data-gathering challenge and get their device on the market. It was Bright’s time to shine.