A thorough understanding of imaging modalities, endpoints and scoring systems allows us to assign scientific experts to match the needs of your study, from protocol design through to regulatory submission.
Bioclinica provides extensive knowledge and experience to the design and implementation of Gastroenterology clinical trials, including protocol design and imaging charter development.
Key Opinion Leaders Specializing in Gastroenterology
Bioclinica has long-standing relationships with a large network of renowned academic and research Key Opinion Leaders (KOLs) who provide expert review, quality assessment, and imaging charter support.
Experienced Operations and Project Management
Navigating the regulatory process
Bioclinica continues to accelerate drug development research, with an unprecedented number of successful, medical image data submissions for many high-profile drugs on the market today. Our experts have a deep understanding of imaging review charter and protocol development, adhering to guidance and directives from the FDA, EMA, and other international regulatory agencies. Our significant experience means effective trial conduct, preparedness for regulatory review and full compliance with 21 CFR Part 11.