20%-30% of people with non-alcoholic fatty liver disease (NAFLD) gradually progress to non-alcoholic steatohepatitis (NASH) by which stage it is characterised by inflammation and liver damage, including various stages of fibrosis. NASH is massively under-diagnosed, partly because it is a silent disease with few, often-mild symptoms and partly because definitive diagnosis is by histopathology of a liver biopsy which the treating physician or patient may prefer not to perform and/or provide.
ICON offers expertise in the development and management of all aspects of NASH clinical trials from the earliest development to the late post – marketing environment. Our clinical trial experience includes:
ICON provides an extensive range of clinical research solutions, along with deep therapeutic area expertise to help you gain insights into the complexities of NASH. Strengthened by the robust infrastructure of a full-service CRO and 26 years of experience in clinical research, our NASH-focused offerings can be engaged anywhere in your clinical development pipeline.
ICON’s fully harmonised and standardised global central laboratory services provide analytical methodologies with industry-leading accuracy for key NASH endpoints.
NASH Biomarker Analysis
Our experienced Project Management teams are available to provide support 24/7 and have the proven ability to deliver in all major regions, including the US, EU, and Asia.
Early Phase Services
Expedite and enhance your clinical development programme by taking advantage of our established population of NASH subjects and expert imaging capabilities, including multiparametric MRI techniques.
Patient Enrolment & Engagement Uncover patients with an underdiagnosed disease
Enhance patient engagement and retention with FIRECREST. With robust training features on biopsy requirements, FIRECREST is an ideal solution for investigator sites that lack experience in NASH.
Optimise phase II and late-phase NASH research through commercial strategy and value-driven communication plans. Our experts provide integrated services for evidence generation, which are designed to enhance value strategy during programme design, product development, and post-marketing.