GASTROENTEROLOGY
We offer extensive preclinical and clinical expertise in the gastrointestinal therapeutic area, with over 15 Phase I/II PK or PD studies involving drugs acting systemically or locally in the GI tract. This includes general toxicology studies in a number of different species, as well as examining preclinical colitis and proctitis models. Our clinical pharmacology capabilities cover all study types, supported by a gastroenterologist Principal Investigator with experience in over 1,000 clinical studies.
Safety or efficacy monitoring is done via endoscopy, colonoscopy, intragastric pH monitoring, and X-ray imaging with barium. Additionally, we have experience with barostat model of colon pain and with PK sampling from ileostomy pouch.
Types of Gastroenterology Trials:
- Drug Trials: Investigate the safety and efficacy of new medications for conditions such as inflammatory bowel disease (IBD), gastroesophageal reflux disease (GERD), or viral hepatitis.
- Endoscopy and Imaging Trials: Assess new endoscopic or imaging techniques for diagnosing and monitoring GI diseases, including colorectal cancer screening or detection of esophageal disorders.
- Interventional Trials: Evaluate specific interventions, such as surgical procedures, minimally invasive techniques, or medical devices for treating GI conditions.
- Nutritional Trials: Investigate the impact of nutritional interventions, dietary modifications, or supplements on GI health.
- Prevention Trials: Focus on strategies to prevent the development or recurrence of GI diseases, including studies on lifestyle modifications, vaccination, or chemoprevention.
Endpoints:
- Common endpoints in gastroenterology trials include improvements in symptoms (e.g., abdominal pain, diarrhea), endoscopic findings, histological changes, and quality of life measures.