Summary
This document is a technical report detailing the expertise and capabilities in delivering clinical trials for inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn's disease (CD). It outlines the established relationships with various clinical sites, which enhance patient recruitment and retention through a comprehensive understanding of site capabilities. The report discusses the development of a new electronic patient-reported outcome (ePRO) tool for UC and CD patients, which is currently being evaluated by the FDA. It emphasizes the challenges posed by a competitive clinical trial environment, including site saturation and the decreasing availability of patients. The document highlights the experience of the PPD Clinical Research team in overcoming these challenges, leveraging a global database of IBD sites and a dedicated operations staff to facilitate successful trial outcomes. Additionally, it notes the importance of digital solutions in improving patient engagement and trial flexibility.
