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.
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 non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) 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.
Imaging Core Lab: Full Service Imaging for Clinical Studies
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.