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Case Study: Crohn’s Disease

This was a global Phase IIb study of a novel biological agent to treat Crohn’s disease for a big Chinese pharmaceutical company. By the moment the Sponsor contacted us their trial had been in active enrollment phase for almost a year in 12 sites in the USA. The company was under an extreme pressure to enroll 50 subjects in six months. In this study OCT provided the following clinical research services to the client:

  • Study Feasibility
  • Project Management
  • Clinical Monitoring
  • Data Management and Statistics
  • Regulatory Management
  • Clinical Supply Management
  • Quality Assurance Services
Due to our experience and close relationships with investigators we managed to identify the best country and sites for this protocol. Such criteria as patient availability, competing studies and country-specific regulatory issues are all considered during feasibility. The feasibility results in countries of OCT presence showed the highest enrollment potential in 6 Ukrainian sites. OCT had a 3 month preparation and approval period and enrolled 30 patients in Ukraine in a four month timeline. Thorough feasibility performed by OCT has guaranteed our success. Through proactive project management, advance planning and the efforts of the dedicated team OCT successfully obtained all necessary regulatory approvals and import/export licenses, and enrolled the maximum possible number of patients within the promised timelines. Crohn's Disease Trial.

Average enrollment per site per month

Crohn's Disease

Crohn’s disease is a chronic inflammatory bowel disease (IBD) which may affect any part of the gastrointestinal tract. All layers of the intestine may be inflamed and with ulcers in Crohn's disease, while ulcerative colitis only involves the innermost lining of the colon.

The causes of Crohn’s Disease are not well understood - most experts agree that the immune system of people with Crohn's disease reacts abnormally. The disease is considered hereditary. In most cases it affects the lower part of the small intestine, ileum. Crohn's is more prevalent among adults between the ages of 15 and 35. The disease is most common among people of eastern European backgrounds. The incidence of Crohn's disease in Russia is 1.5 per 100000.