Gastroenterology CRO

Disorders of the gastrointestinal tract, liver and pancreas affect millions of people worldwide. Drug developers are working tirelessly to offer them hope – a cure, relief from symptoms and avoidance of surgery. Every day, exciting advances for effective treatments are being made in many GI conditions such as ulcerative colitis, Crohn’s disease, celiac disease, metabolic dysfunction-associated steatohepatitis (MASH), and other highly complex disorders.

The race is on to bring novel products to market that have both efficacy and acceptable safety profiles to patients. Multiple trials running in tandem result in intense competition for trial participants, even as patients struggle with side effects and sometimes drop out of clinical trials. In the case of immune-suppressive medications, recruitment can be impeded by legitimate concerns about the risks of serious side effects. For new drugs targeting rare diseases and specific pathways, finding the right patients presents a unique challenge. Due to these challenges, a highly specialized expertise is required for clinical trial protocol development, site feasibility, and executing on-time, on-budget and with first time quality.

Parexel is a leader in this area, applying not only strong medical knowledge but a deep understanding of the challenges drug developers currently face in conducting clinical trials in gastrointestinal diseases. We draw upon longstanding relationships with patient advocacy groups, key opinion leaders, and alliance sites, and develop strategies specific to each trial for recruiting and retaining participants. In addition, we collaborate with our colleagues in endocrinology and other closely related fields, who are a rich source of medical knowledge in metabolic diseases.

As an example of meeting these challenges, we recently conducted an adaptive Phase II/III study for moderate to severe ulcerative colitis involving approximately 550 subjects in more than 35 countries. Initially, enrollment was slow due to invasive assessments and strict inclusion criteria, exacerbated by concerns about subcutaneous injection drug administration and competition from approved oral medications. Through focused communications (newsletters, regional investigator meetings, focused Q and A sessions), site training, and additional incentives to screen and enroll patients, we were able to achieve accelerated site activation and accelerated subject screening. In this competitive environment, we achieved last subject/first visit 11 days ahead of the projected milestone. 

We were a key partner on recent new drug approvals for Crohn’s disease in China and the U.S. in 2025