Clinical drug development for digestive disorders and diseases, such as inflammatory bowel disease and
functional GI disorders, presents a unique set of challenges for developing new and effective treatments.
Medpace, a therapeutically-specialized gastroenterology CRO, can help Sponsors design and execute drug development strategies while also providing critical integrated services such as centralized
imaging and central labs.
Therapeutic Leadership Across Multiple Indications
As a physician-led, therapeutically-focused global CRO, Medpace offers medical
leadership in GI, as well as other areas that may cross over into GI studies
Infectious Disease, Metabolic/Diabetes, and
Oncology. Our team
approach provides sponsors with valuable insights from highly
experienced medical doctors into studies that touch on multiple indications.
In addition, Medpace employs a seasoned team of CTMs, CRAs, data managers,
statisticians, safety managers, medical writers, and regulatory managers who are
focused on serving sponsors in all of your clinical development needs.
Gastrointestinal Drug Development Expertise
- Inflammatory Bowel Disease including:
- Ulcerative Colitis
- Crohn's Disease
- Functional GI Disorders including:
- Chronic Idiopathic Constipation (also drug-induced constipation)
- Irritable Bowel Syndrome
- Postprandial Distress and Gastroparesis (also GERD)
- Liver Disease including:
- Viral Hepatitis
- Nonalcoholic steatohepatitis (NASH)
Endoscopy has become a standard outcome measure in many GI indications
including IBD. The concept of mucosal healing and deep remission in Crohn’s
Disease and Ulcerative Colitis has gained momentum with regulators and
prescribers. Centralized imaging allows for standardization of patient inclusion
and outcome assessment.
Imaging Core Lab, a wholly owned subsidiary of Medpace,
provides holistic central imaging service including site assessment,
qualification and training, recording equipment provisioning, image processing
(blinding and quality control) and expert evaluation.
Full-service Central Lab for GI Studies
Medpace Reference Labs (MRL) provides global central laboratory services through
four wholly owned labs located in Belgium, China, Singapore and the USA. Unlike
other global central labs that are grown through acquistion, MRL labs were
custom built and offer identical testing platforms, reagents, calibration and QC
to ensure identical results globally. As a full service central lab, MRL can
help design and execute your protocol testing needs with a strong selection of
inflammatory biomarkers and cytokines.