Therapeutic Expertise
Gastroenterology & Hepatology
Our GI and hepatology team runs trials across inflammatory bowel disease, IBS, viral hepatitis and liver disease, combining endoscopic endpoint expertise with validated patient-reported outcomes.
Gastroenterology endpoints often combine endoscopic/histologic assessment with symptom-based patient-reported outcomes, both of which need standardisation. We provide central endoscopy reading, validated PRO capture and physician oversight to deliver regulator-ready efficacy data.
Addressing common pain points in gastroenterology & hepatology clinical trials
Endoscopic scoring variability
Endoscopic and histologic endpoints vary between local readers.
We use centralised, blinded endoscopy and histology review to standardise scoring.
Symptom-based endpoints
IBS and IBD rely on PROs that are sensitive to design and placebo effects.
We deploy validated, well-controlled PRO instruments to protect assay sensitivity.
Complex regulatory endpoints
FDA and EMA have specific expectations for GI efficacy endpoints.
We align endpoints and analysis with current regulatory guidance early.
Resources
Gastroenterology & Hepatology clinical trial resources
IBD Treatment Drugs Approved, Failed, and Lessons Learned
Lessons from the IBD development landscape.
The Road to FDA Approval in IBS Clinical Trials
Endpoint and approval strategy in IBS.
Understanding Hepatitis B Clinical Trials
Trial design considerations in hepatitis B.
Evidence & insights
Gastroenterology & Hepatology white papers
Open-access reports from our physicians and data science teams — free, no sign-in.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Gastroenterology & Hepatology clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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