Supporting Clinical Research in Gastroenterology & Hepatology
Digestive and liver diseases affect millions worldwide – driven by diets, environmental exposures, genetics, and rising stress levels. With over 40% of the global population suffering from functional gastrointestinal disorders or over 30% from MASLD/MASH alone, the need for effective, innovative treatments has never been greater. Medpace is the leading GI and hepatology CRO with experience across Phase I-IV gastroenterology and hepatology trials, supporting a broad spectrum of indications. As a full-service CRO with a proven track record, we deliver the scientific insight, operational excellence, and flexibility needed to navigate the complexities of each study and accelerate progress for patients.
Making the Complex Seamless in GI & Hepatology Clinical Development
GI & Hepatology CRO Expertise
Medpace brings deep, global experience across a broad spectrum of gastrointestinal and liver diseases – from common to complex and rare indications. Our in-house medical leadership and therapeutically aligned operational teams bring proven expertise that drives high-quality execution and accelerates timelines. We’ve supported successful trials in both early and late phases across key GI and hepatology indications, including:
- Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease
- Esophageal and gastric disorders, including GERD, NERD, eosinophilic esophagitis, and gastroparesis
- Functional gastrointestinal disorders, including irritable bowel syndrome, functional constipation, and functional diarrhea
- Metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated steatotic liver disease (MASLD), including MASH-related cirrhosis
- Alcoholic hepatitis and rare liver diseases such as Wilson’s disease, alpha-1 antitrypsin deficiency,
PBC or PSC - Critically ill and ICU patient populations, including complex studies in hospitalized settings
Optimized Site Selection with Proven Partnerships
Accelerate your GI and hepatology trials through Medpace’s data-driven feasibility strategy and strong site relationships. Our IntelliPACE® model synthesizes internal and external data sources to pinpoint the most suitable countries and sites, while our dedicated patient recruitment and retention team ensures expedited enrollment and reduced dropouts.
Further enhance your site selection through Medpace Flagship Sites – an established group of top performing global sites and site networks with a proven track record of delivering timely, quality outcomes. Our deep, long-standing relationships with these sites, along with preferred partnerships with key site networks in the U.S., Asia, and Europe, streamline study start-up, enhance patient recruitment, and ensure high-quality data capture. Regular engagement with site leaders keeps studies running efficiently while maintaining Medpace’s high standards for study execution.
Comprehensive Lab Support
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. Combined with Medpace CRO expertise, we provide a fully integrated solution for your clinical development needs.
Histology & Anatomic Pathology Services
Medpace’s histology services complement the central lab’s continually expanding molecular and flow cytometry capabilities to help Medpace manage clinical trials across a wide range of indications, including MASH, eosinophilic esophagitis, inflammatory bowel disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, and primary sclerosing cholangitis. We have been proactive in implementing testing capabilities that match the spectrum of gastroenterology and hepatology clinical development approaches needed to support pharmaceutical industry partners..
Imaging Core Lab
Leverage our integrated imaging core lab, which brings together scientists, clinicians, technologists, project managers, and coordinators to seamlessly incorporate both standard and novel GI and liver biomarkers into clinical trials – from concept through design and execution. Centralized imaging allows for the standardization of patient inclusion and outcome assessments, including endoscopy-based measures. While mucosal healing and deep remission have become standard endpoints in IBD trials such as those for Crohn’s disease and ulcerative colitis, our expertise also extends to centralized endoscopy review in upper GI studies and in liver disease trials, including cirrhosis studies where endoscopic screening for varices is used for patient eligibility.
Over the last decade, our imaging core lab has developed thorough expertise of MR imaging in various gastroenterology and 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.
Collaborative & Cross-Functional Teams to Execute Your GI & Hepatology Study
At Medpace, collaboration is at the core of our success in GI and hepatology clinical research. Our integrated teams – spanning medical, regulatory, and operational experts – work seamlessly to provide strategic oversight and execution at every stage of development. This synergy allows us to anticipate challenges, adapt strategies, and drive meaningful advancements in GI and hepatology disease research. Explore our expert leaders who are shaping it:
Piotr Krzeski, MD, PhD, FFPM
Vice President, Medical Department
Dr. Krzeski is a board-certified internist with an extensive background in pharmaceutical research. Specializing in GI and hepatology indications, he brings over 25 years of experience in Inflammatory Bowel Diseases, Functional GI Disorders, cholestatic liver diseases, MASLD and MASH. Dr. Krzeski is recognized in the field for his contribution to the pioneering work on standardization of central imaging in drug development, and is a member of AASLD, AGA, and Fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians UK.
Shinichi Asabe, PhD, MD
Sr. Medical Director
Dr. Asabe is a board-certified gastroenterologist and hepatologist with expertise in clinical research for drug development in GI and immunology, including 10+ IBD studies. He has a PhD in Microbiology with research experience in virology, immunology, and oncology, and brings over 16 years of experience serving as a Hepatology Division Head of a university hospital. Additionally, Dr. Asabe offers clinical and basic research experience in autoimmune and drug-induced liver disease, including immune-related cholestatic liver dysfunction.
Frénel Joseph
Therapeutic Group Lead, Gastrointestinal
Sr. Director, Clinical Trial Management
Mr. Joseph holds a Master of Science in cellular biology and physiology and a Certificate of Methodology and Statistics in medical research, DIU CESAM from Pierre & Marie Curie University, Paris VI. He brings 24 years of experience in Lifecycle Management and Project Management of international clinical trials mainly at CROs and Pharma industry. Throughout Mr. Joseph’s career he has successfully managed all clinical development aspects of several global Phase 1-4 clinical research projects from start-up to completion. Mr. Joseph has successfully led global programs in several different therapeutic areas, including gastrointestinal indications such as Crohn’s disease, Ulcerative
Colitis (UC), and IBS.
Rob Richardson, MBA, MSN, RN
Sr. Associate Director, Clinical Trial Management
Mr. Richardson brings over 20 years of experience in clinical research, with experience in CROs with clinical monitoring and clinical trial management. His extensive experience includes Phase 1-3 in multiple therapeutic areas including gastrointestinal indications such as UC, Crohn’s disease, PFIC, PSC, MASH, GERD, EE, and rare disease. Mr. Richardson also brings 24 years of experience with 15 years of clinical experience as a nurse in emergency medicine, trauma, and critical care.
Comprehensive IBD Clinical Trial Support
Medpace offers deep therapeutic expertise and global operational experience in managing clinical trials for inflammatory bowel disease (IBD), including both Crohn’s disease and ulcerative colitis. We understand the unique challenges of IBD trials, including recruitment and retention and the need for centralized endoscopy and histopathology review. Our understanding of these complex conditions helps us position our Sponsors 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. Combined with our proven processes and global site relationships, Sponsors can overcome these hurdles and advance their IBD therapies with confidence.
