NAFLD / NASH
State-of-the-Art Assessment of NAFLD/NASH Subjects
The Bioclinica Medical Imaging service utilizes our therapeutic expertise and best in-class image analysis and systems to provide comprehensive Non-Alcoholic Fatty Liver Disease (NAFLD) /Non-Alcoholic Steatohepatitis (NASH) trial support – from start to finish.
At Bioclinica, we perform independent central review of non-invasive magnetic resonance imaging (MRI) techniques in clinical trials to expedite the assessment of disease severity and provide a more accurate monitoring of therapeutic response. Through our understanding of the complexities of NAFLD/NASH endpoints and broad therapeutic expertise, we help customize the imaging end points to the goals and objectives of your clinical trials.
We understand the complexities of imaging endpoints required for NAFLD/NASH and utilize our best-in-class image analysis and systems to provide sponsors with comprehensive clinical trial support – from the start of your trial (protocol design and imaging charter development) to internal/external presentations, all the way through the eventual regulatory submission.
Paving the Way for Improved Assessment and Monitoring for Change
Our experts are leading research to change the way liver disease is monitored. Surgical biopsy, which is the current diagnostic standard, is invasive, expensive, and painful – and only provides information from a small part of the liver. The use of biopsies alone can delay diagnosis and treatment – often until cirrhosis or liver cancer is present. At Bioclinica, we support the use of highly accurate blood tests and non-invasive imaging techniques, such as MRI, to expedite the assessment of disease severity and provide more accurate monitoring of disease changes in clinical trials. Advanced medical imaging can provide important, quantitative information on changes in the liver, informing patient eligibility and drug efficacy. Therefore, we work with each client to customize the biomarker and imaging package to the goals and objectives of the clinical trial.
Enhanced Capabilities for Sponsors
Enroll and retain subjects with timely image reads that are right the first time.
- Comprehensive training of MRI facilities to ensure high quality images are collected, minimizing repeat examinations
- Achieve 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
- Stay on top of trial status with real-time access to eligibility and safety reports
- Transfer a wide range of image formats to external vendors and partners
Clinical Trial Experience from Methods Development to Phase 3
The Bioclinica Advantage
Leverage our therapeutic expertise, regulatory leadership and global operations to design and expedite your NAFLD/NASH clinical trials, from protocol development to regulatory submission.
- Robust site setup and qualification of imaging personnel and equipment
- Comprehensive training on image acquisition
- Extensive quality review of incoming data
- Precise measurement of liver fat fracture (proton density fat fraction) and liver stiffness (MR elastography)
- Rapid eligibility analysis by global internal readers
- 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
- 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
Our NAFLD/NASH team is committed to the success of your study. We work closely with sponsors and sites to oversee qualitative and quantitative endpoints, and deliver high-quality data for eligibility, safety, and efficacy studies.
From Our INDUSTRY PROFESSIONALS
Blood and Urine Tests Commonly used in NAFLD/NASH Clinical Trials
What does the best NAFLD/NASH clinical trial protocol look like? That’s a difficult question to answer because there is no…