Gastroenterology & Hepatology

Problem:

Many gastrointestinal and liver conditions have fluctuating symptoms that are subjective and difficult to quantify, making it challenging to assess treatment efficacy based on clinical outcomes alone. Additionally, the invasive nature of some diagnostic procedures can deter patient participation in clinical trials.

iNGENū CRO addresses this pain point with Patient-Centric Approaches:

Emphasising patient-reported outcomes offers insights into the real-world impact of interventions on patients’ lives. It is crucial to consider the personal experiences of patients, given the intimate nature of many GI symptoms.

Problem:

The complexity of diseases like IBD, NASH, and liver fibrosis requires precise biomarkers for early diagnosis, disease progression monitoring, and therapeutic response evaluation. However, biomarker discovery and validation remain a significant challenge in gastroenterology and hepatology trials.

iNGENū CRO addresses this pain point with 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.

Problem:

Traditional diagnostic methods such as biopsies and endoscopic procedures can be invasive, costly, and associated with patient discomfort. Moreover, standard imaging techniques may lack the sensitivity required for detecting early-stage disease changes.

iNGENū CRO addresses this pain point with Advanced Imaging Techniques:

Non-invasive techniques like endoscopic ultrasound or MRI enterography assess disease severity and therapeutic response without significant discomfort to the patient.

Problem:

Gastrointestinal and liver disorders encompass a broad spectrum of diseases with different aetiologies and progression rates. A one-size-fits-all protocol may fail to address the specific nuances of these conditions, leading to suboptimal study designs.

iNGENū CRO addresses this pain point with Tailored Protocol Development:

We specialise 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.

Problem:

Many GI and hepatology conditions have heterogeneous patient populations with varying disease severity, comorbidities, and treatment histories, making patient stratification crucial for obtaining meaningful results.

iNGENū CRO addresses this pain point with 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.

Problem:

Gastroenterology and hepatology trials often involve complex regulatory requirements, particularly when testing new biologics, advanced therapeutics, or combination therapies. Navigating ethical concerns related to invasive procedures also adds to the regulatory burden.

iNGENū CRO addresses this pain point with Regulatory Expertise:

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.