Gastroenterology &
Hepatology CRO

Specialized gastroenterology and hepatology expertise to support clinical trials covering a wide range of digestive and liver disorders.

Specialized gastroenterology and hepatology expertise to support clinical trials covering a wide range of digestive and liver disorders.

endoscope in hands of experienced medical worker

Supporting Clinical Research in Gastroenterology & Hepatology

Gastrointestinal, liver and nutritional disorders are a global concern.  More and more people recognize that gastrointestinal and liver health are impacted by diet, environment, genetics and the heightened level of stress in the modern world that we inhabit. For example, data  indicates that over 40% of persons worldwide suffer from functional gastrointestinal disorders. Novel therapies are desperately sought after to improve the quality of life for millions. Medpace has global experience in Phase I-IV gastroenterology (GI) and hepatology studies for a broad spectrum of gastrointestinal indications. Our expertise in GI clinical research and consistent track record of success as a full-service CRO provide the knowledge and flexibility to adapt to the unique needs of each trial.

The Medpace Advantage

Leverage our medical expertise, global regulatory knowledge, operational experience, and cross-functional, collaborative therapeutic teams to develop custom strategies that expedite study start-up times, keep patients engaged, bypass pitfalls, and accelerate the licensing of life-changing therapies.

Gastroenterologist doctor consulting woman in clinic

Gastroenterology & Hepatology CRO Capabilities

Our deep understanding of the complex conditions that cause GI disorders helps us position our clients for success. In fact, our in-house experts pioneered award-winning work that is validated and internationally recognized in the standardization of centrally reviewed endoscopy for inflammatory bowel disease research. Their leadership in bench to bedside translational science in GI disease has already provided life-saving and life- changing improvements in patient care. Additionally, our diagnostically and therapeutically trained operational teams, including clinical trial managers and program coordinators, have the relevant and recent GI and hepatology experience in indications ranging from GERD to NERD, IBD, Gastroparesis, Eosinophilic esophagitis, Celiac disease to metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated steatotic liver disease (MASLD) (formerly known as NASH/NAFLD) or cholestatic liver diseases to successfully navigate the complexities and regulatory scrutiny often involved with these programs.

Our experience with global regulatory authorities, coupled with early planning and collaboration with Sponsors, accelerates the path to approval. Our knowledge of effective GI trial design and patient eligibility criteria allows us to manage potential challenges and logistical requirements associated with screening and enrolling GI patients, accelerating recruitment timelines.

Imaging Core Lab

Benefit from our integrated imaging core lab comprising a team of scientists, clinicians, technologists, project managers, and coordinators,  that can successfully integrate standard and novel GI biomarkers into studies from concept through design and execution. Centralized imaging allows for the standardization of patient inclusion and outcome assessments, including endoscopy for mucosal healing, and deep remission has become a standard outcome measure in IBD indications such as Crohn’s Disease and Ulcerative Colitis.

Over the last decade, our imaging core lab has developed thorough expertise of MR imaging in various gastroenterology/hepatology indications such as MRI PDFF or MRE, with proprietary processes, internal and external central reviewers. Our imaging core lab provides holistic central imaging services, including site assessment, qualification and training, recording equipment, provisioning, image processing (blinding and quality control), and expert evaluation.

doctor examination abdominal x-ray film

Fact Sheet

Imaging Core Lab: Full Service Imaging for Clinical Studies

Close-up of a doctor gloves working in a testing laboratory
Fact Sheet

Comprehensive Central Laboratory Services

Integrated Central Laboratory

Medpace central laboratories offer global lab services, including an extensive menu of inflammatory biomarkers and cytokines that use state-of-the-art techniques for all stages of the development process. Focused on both the scientific and service aspects with four wholly-owned laboratories in the US, Europe, China, and Singapore, our central lab has the global reach to support studies, assist with regulatory requirements and deliver custom solutions for any need.

Comprehensive Regulatory Affairs and Operational Expertise

Medpace has built a team of therapeutically-aligned operations and regulatory experts who work collaboratively with our specialized medical team to manage and execute gastroenterology trials encompassing Sponsor/CRO project management and site study coordination from the patient care perspective. A best-fit, cross-functional team is assigned to each project upon initiation, and typically remains in place through trial completion, producing seamless drug development.

Young female doctor sits with a senior patient