Case Study
Specialty Medical Device Company Accelerates Study Builds with Functional Service Provider Partnership
PROJECT BACKGROUND Medical device clinical trials come with unique requirements including growing regulatory scrutiny and the need for data integration and speed to market. As a result, device companies often face challenges in effectively building out clinical trial electronic data capture (EDC) systems that can accommodate their studies across the lifecycle of their products.
COMPANY PROFILE ■ ■ ■
Medical Device Company in Niche Indication Headquartered in United States Approx. 150 employees
PRODUCTS UTILIZED ■ ■
Clinical Data Acquisition Functional Service Provider
THE CHALLENGE A medical device company specialized in developing innovative solutions for an area of high unmet need sought to improve their study build process. The company’s portfolio of medical device studies is diverse, with requirements varying significantly from study to study. Additionally, the company has a range of specific requirements as a study sponsor, calling for an EDC build approach that the client could tailor to meet their unique needs, and that would be flexible enough to
accommodate changes between studies. The sponsor has an expert, but small clinical data management and clinical programming internal team so needed to ensure exceptional quality and strong working relationships with their outsourced partner. In addition, due to the number of studies which the group expected to handle, they wanted to embed efficiencies over sequential builds and accelerate their kick-off meeting to database go-live timeline.