State-of-the-art NAFLD/NASH assessment
Clario’s therapeutic expertise and our best-in-class image analysis and systems provide you with comprehensive Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) clinical trial management and study support — from start to finish.
When combined with clinical data, our non-invasive imaging techniques expedite the assessment of disease severity and provide you with a more accurate picture of disease changes. Through our understanding of the complexities of NAFLD/NASH endpoints, our liver clinical trial management experts can help you customize a biomarker and imaging package specific to your trial’s goals and objectives.
Changing the way liver disease is monitored
Surgical biopsy, the current diagnostic standard, is invasive, expensive, and painful. Biopsies also only provide information from just a small part of the liver, so relying on biopsies alone can often delay diagnosis and treatment — often until cirrhosis or liver cancer is present. At Clario, our liver clinical trial team utilizes advanced medical imaging to provide important, quantitative information on liver changes in NAFLD/NASH patients — useful data to help inform patient eligibility and to determine drug efficacy.
Hepatology experience
55+
Liver/Muscle Dixon studies
20+
Liver studies with MRI-PDFF, MR Elastography and SAT/VAT depot analysis
320+
Study sites
2,225+
Magnetic resonance imaging. Proton density fat fraction (MRI-PDFF) analyses
750+
MR elastography (MRE) analyses
600+
SAT/VAT segmentation
Improving enrollment and retention with timely image reads that are right the first time
- Accurate, consistent, reliable measurements through independent, software-assisted review of liver images and quantitative analysis
- Data quality ensured by expert radiologist review of every measurement and our reader monitoring program
- Trial status updates are easy with real-time access to eligibility and safety reports
- A wide range of image formats supports transfer/archiving to external vendors and partners
Overview
Leverage our therapeutic expertise in liver clinical trial management and nephrology studies, our regulatory leadership and our global operations to design and expedite your NAFLD/NASH clinical trials, from protocol development to regulatory submission.
Expertise
- Guidance to identify the optimal modalities for screening specific to your study’s needs
- Determination of trial-specific liver endpoints
- Measurement of liver fat and stiffness as well as subcutaneous and visceral adipose tissue compartments
- Development of imaging protocols and imaging charter
- Design of independent review methodology
Services
- Robust site setup and qualification of imaging personnel and equipment during the liver clinical trial management process
- Comprehensive training on image acquisition
- Extensive quality review of incoming data
- Precise measurement of liver fat fraction (proton density fat fraction) and liver stiffness (MR elastography)
- Rapid eligibility analysis by global internal readers
Experience
- Pairing the right biomarker and liver measurements with the specific trial goals
- Facilitating patient enrollment through timely image reads
- Retaining patients by minimizing the need for repeat scans
Capabilities
Our experience covers the complete range of imaging modalities for hepatology research, including:
- Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF)
- Magnetic Resonance Elastography (MRE)
Focus areas
Our experience includes imaging support for the following indications and areas:
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Non-Alcoholic Steatohepatitis (NASH)
- Compensated/Decompensated Cirrhotic liver stiffness
- Varices in NASH
Talk to a specialist
Our team of experts is available to address any questions you may have about our hepatology solutions. Submit your contact information and we’ll be in touch shortly.