Gastroenterology

It is estimated that gastrointestinal (GI) diseases affect 60 to 70 million US citizens annually. Based on a 2008 report from the NIDDK¹, the prevalence of this disease area has led to an estimated $142 billion per year in direct and indirect costs for treatment. It is therefore no surprise that this is an active area of research with many organizations focused on bringing new and effective therapies to address the wide array of diseases in this sector to market.

Strong competition within the industry to develop these products presents significant challenges to conducting these clinical studies, including the identification and enrollment of appropriate patients into these trials.

CRMG’s successful clinical research experience in gastroenterology sets us apart from the competition. Our strategies and best practices include the ability to identify investigative sites that have a track record for successful enrollment, and developing effective patient recruitment and retention plans. These proven methodologies ensure that our sponsors meet their critical clinical milestones. Furthermore, our recent experience in this area has allowed CRMG to develop close relationships with gastroenterology investigators and key opinion leaders (KOLs) across North America (NA).

Our experience in knowing how to partner with investigators to achieve a win/win scenario for both site and sponsor is what separates us from other service providers. We have observed that time and again, our approach leads to successful study completion on time or ahead of schedule, and moreover, keeps investigators interested in working with CRMG and our sponsors on future programs.

Experience

With experience in Phase II & III studies, as well as Phase IV safety surveillance programs, we have conducted trials in recent years in the following:

Inflammatory bowel diseases
Fecal incontinence

1. Everhart JE, ed. The Burden of Digestive Diseases in the United States. Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases, U.S. Department of Health and Human Services; 2008. NIH Publication 09–6433

Study Brief: Gastroenterology

Summary

Based on CRMG’s reputation in the industry for delivering in highly competitive clinical environments, a large multi-national pharmaceutical organization approached CRMG to support the North American (NA) clinical operations & safety elements of a Phase II, randomized, multi-center, double-blind, placebo-controlled trial for a new chemical entity in patients with mild to moderate active ulcerative colitis.

Key Facts and Figures

Study duration: 12 months from study start to completion of enrollment
Required enrollment for NA: 90 subjects
Number of sites initially estimated: 26

Accomplishments

At the outset, the sponsor’s goal was to enroll 90 patients in the NA and 35 patients in Europe, and complete the study in 12 months. CRMG was able to enroll its 90 patients in NA ahead of schedule. Given the lack of enrollment from the sponsor’s efforts in Europe, CRMG was asked to continue enrolling the remaining 35 patients. CRMG reacted quickly, identifying, qualifying and initiating an additional 9 sites in a matter of weeks. In the end, CRMG was able to enroll the full 125 subjects, with minimal impact to timelines and cost. Given our ability to execute and respond to our client’s needs, we continue to collaborate with this sponsor to date, supporting additional studies for this important therapeutic agent.