Most clinical trial sponsors and CROs often turn to third-party imaging vendors to meet regulators’ requests for quantitative imaging data during clinical development. However, few of these third-party firms have the combination of knowledge, technology, and creative problem-solving that can be critical to meeting researchers’ needs.
A Medtronic business unit, formerly Covidien, chose ERT as its clinical research imaging vendor to develop an entirely new research approach that would make the case for the superiority of its graduated-height surgical staples.
How ERT’s Creativity and Scientific Experience Provided Value to Medtronic
Because ERT develops and uses its own validated software, it can quickly configure the application to meet the unique requirements of virtually any imaging study.
In this case, ERT used micro-computed tomography (micro-CT) and other novel perfusion and image-analysis techniques to provide the scientific evidence Medtronic needed to support its product superiority claim, which has been published in Medical Devices: Evidence and Research.
ERT’s Imaging Solution
In this example, ERT:
- Leveraged several capabilities that other third-party imaging vendors often lack
- Designed innovative imaging study protocols and exploratory endpoints in a previously unexplored area
- Demonstrated that it has the ability to create and successfully execute a novel study
- Validated a new kind of micro-CT imaging endpoint