Gastroenterology & Hepatology

Gastroenterology and hepatology trials tackle complex challenges across varied disease types. A patient-centric approach, combined with advancements in research and diagnostics, promises more effective therapies in the future.

We offer extensive experience across a range of gastroenterology and hepatology conditions, including:
  • Inflammatory Bowel Disease (IBD)
    Crohn's Disease
    Ulcerative Colitis
  • Gastroesophageal Reflux Disease (GERD)
  • Irritable Bowel Syndrome (IBS)
  • Gastrointestinal Cancers
    Gastric, Colorectal, Pancreatic, Esophageal
  • Liver Diseases
    NAFLD, Hepatitis, Cirrhosis

Pain points experienced with gastroenterology and hepatology clinical trials

  • Inflammatory Bowel Disease
    Diverse Symptomatology: Wide symptom range complicates standardized efficacy endpoints.
    Patient Recruitment: Chronic nature makes eligible patient identification hard.
  • Gastroesophageal Reflux Disease
    Adherence to Treatment: Ensuring patient compliance in long-term trials.
    Safety Monitoring: Potential off-target effects of GERD-targeting drugs.
  • Irritable Bowel Syndrome
    Placebo Response: High placebo response rate challenges the determination of true drug efficacy.
    Diverse Symptomatology: Patient symptoms vary widely, complicating standardized measures.
  • Gastrointestinal Cancers
    Regulatory Concerns: Meeting evolving standards set by regulatory bodies.
    Patient Recruitment: Due to the severity of the disease, patient attrition rates can be high.
  • Liver Diseases
    Biomarker Validation: Need for reliable biomarkers to measure disease activity and therapeutic response.
    Patient Adherence: Ensuring consistent treatment follow-through, given the slow progression of some liver diseases.

How iNGENū addresses these pain points

  • Patient-Centric Approaches: Emphasizing patient-reported outcomes offers insights into the real-world impact of interventions on patients' lives. It's crucial to consider the personal experiences of patients, given the intimate nature of many GI symptoms.
  • Biomarkers: These provide objective measures in conditions like IBD and liver diseases. The push for development and validation of biomarkers can streamline both diagnosis and treatment.
  • Advanced Imaging Techniques: Non-invasive techniques like endoscopic ultrasound or MRI enterography assess disease severity and therapeutic response without significant discomfort to the patient.
  • Tailored Protocol Development: We specialize in custom protocol development that acknowledges the diverse disease spectrum in gastroenterology and hepatology, ensuring each trial is specifically designed to target the intended condition and outcome.
  • Advanced Patient Stratification Techniques: By leveraging state-of-the-art analytics and patient databases, we can identify and recruit patients that fit specific trial criteria, reducing variability and ensuring a homogeneous trial cohort.
  • Ethical and Regulatory Navigation: With a dedicated team of regulatory experts, we assist in streamlining the regulatory process, ensuring that all clinical trials comply with ethical guidelines and the latest regulations.
Ready to discuss your trial?