Clinical Research Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to established and emerging medical device companies. The following case studies describe specific clinical research solutions that we have tailor-made for clients that develop and manufacture medical devices.
A small, innovative US company requested regulatory support for submission of a 510(k) for a new medical device. The lack of internal expertise and infrastructure threatened this client’s ability to successfully achieve their business objectives. Beaufort was initially brought in for regulatory support, but as the project progressed, the client realized they needed assistance with clinical trial management as well. Beaufort created a collaborative environment to carry out the many responsibilities with the various partners in order to achieve the necessary results, including 510(k) clearance of this client’s medical device.
A company that offers comprehensive contract manufacturing services required regulatory and clinical support. The company needed a clear regulatory strategy for bringing their project to market in the shortest possible timeframe. In addition, the client needed clinical trial management and data entry to support a 510(k) submission to FDA. Beaufort provided ongoing regulatory consultation and conducted the clinical trials, including site identification/qualification, clinical study and regulatory document preparation, IRB submissions, site monitoring, and data entry in support of the company’s first 510(k) submission to FDA.
