Case Study: Non-interventional Digital Imaging Study

Challenge

The client needed real-world samples of digital x-ray images to further the development of a medical device

The client needed to ensure that the device would be compatible across the majority of digital x-ray systems so the sample needed to be sufficiently large to provide a robust analysis

Approach

We designed, planned and executed a prospective, non-interventional UK real-world study

Supporting the client through every stage from Health Research Authority (HRA) and Research Ethics Committee (REC) approval, through to recruitment  and monitoring of study sites as well as data gathering and collation.

We also managed several protocol amendments with the HRA

Outcome

The study enabled the client to validate its new medical device analysis software and prepare for a commercial launch

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