With experience in a number of novel device trials we can provide a full statistical consultancy service or oversee the statistical aspects when CROs are carrying out the clinical trial work.
We also work with a network of freelancers who between them can provide all aspects of running smaller medical device trials; project management, CRF design, database design, regulatory guidance, ethics applications and writing clinical study reports. This virtual office of freelancers can be much more efficient than employing a large CRO, who also often have no experience of medical device trials.
Kim previously worked for Johnson & Johnson Medical on their wound care dressing trials. Following that she worked on a large HTA trial evaluating mattresses designed to prevent pressure ulcers. Her medical device experience has included working on prognostic factors for wound healing, randomised controlled trials of surgical smoke removal, circulatory guidance device during anaesthesia, coagulation devices during surgery, wound scaffolds and cartilage replacement in orthopaedic surgery.