Inflammatory Bowel Disease


Over five million people around the world suffer from Inflammatory Bowel Disease (IBD), which includes Ulcerative Colitis (UC) and Crohn’s Disease (CD) and the incidence has been steadily rising.

The area is one of the most active in biopharmaceutical development, with hundreds of trials in progress, many with the potential to deliver breakthrough therapies. Trial participants typically are suffering from active flare-ups, and competition for highly specialized investigators and interested patients is intense.

At ICON, we’re able to surmount the challenges you face in IBD development by bringing deep therapeutic expertise, process and technology innovation, and an integrated approach to the full course of compound development. In the past seven years, we’ve conducted:

  • 46 studies in IBD
  • Involving 4,500 patients
  • At nearly 4,000 sites worldwide

ICON can provide the following:

  • Strategic Development Services: clinical development plan development to define your regulatory strategy and analyzing licensing opportunities.
  • Optimal Study Designs: adaptive design strategies in Phase I-III trials.
  • Dedicated Early-Phase Services: First-in-Human (FIH) through Proof of Concept (POC) studies
  • Commercialization and Outcomes Support: demonstrate your product’s unique clinical outcomes and economic impact
  • Extensive Site Relationships: alliances with a vast pool of Key Opinion Leaders (KOLs) and gastroenterologists with a proven ability to enroll IBD patients and provide quality data.
  • Sophisticated Patient Recruitment and Engagement: Clinical Enrollment Mangers (CEMs) working to keep investigators and patients engaged, using technology tools and innovative communication strategies
  • Experienced Medical Imaging: Our 200+ medical imaging specialists are highly trained in the multiple imaging modalities used in IBD and work closely with GI Reviewers, a network of independent gastroenterologists who serve as central readers
  • Convenient, Central Laboratory Services: global network of wholly owned laboratories speeds the data collection process and perform analyses using a range of key IBD biomarkers
  • Advanced Data Analytics: The ICONIK Informatics Hub serves as the nerve center for your trial’s operational, clinical, and real-world data