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NAFLD / NASH

Expertise in Imaging for Fatty Liver Commonly Associated with NAFLD / NASH

Bioclinica delivers therapeutic expertise, regulatory leadership, and global operations to inform and expedite Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) 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) all the way through to regulatory submission and archiving of image data.

The Bioclinica Advantage

 

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support your next trial.

CONTACT US Brochure

 

Paving the Way for Improved Detection, 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 in 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.

  •   Robust site setup and qualification

  •   Extensive quality review of incoming data

  •   Rapid eligibility analysis by global internal readers (2- to 3-day turnaround)

  •   Determination of trial-specific liver endpoints

  •   Measurement of liver fat levels as well as intramuscular, 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

  •   Determining collect-and-hold strategies to maximize imaging investments

  •   Facilitating patient enrollment through timely image reads

  •   Retaining patients by minimizing the need for repeat scans

 

Bioclinica's Application of SMART for NAFLD / NASH

Bioclinica advances clinical trials via SMART — a robust suite of centralized medical imaging services designed to manage the complex imaging process from image receipt to analysis to regulatory submission.

Your trial depends on the selection and accurate measurement of liver endpoints. Advanced medical imaging can provide important, quantitative information on changes in the liver, informing patient eligibility and drug efficacy. Our experts have experience with all modalities including the latest advancements in liver imaging, allowing for an innovative solution for your trial endpoint requirements.

Modality Endpoints
Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF) Fat Levels
Magnetic Resonance Elastography (MRE) Stiffness – to identify level of fibrosis

Images are electronically uploaded from trial sites, blinded and rigorously quality checked. Bioclinica employs a "Multi-Step Quality Control" process that ensures the image data received from the sites will be of the highest quality. Our standard and automated process and solutions provide the ability to uniquely adapt to your trial.

We track all patients enrolled in studies and all imaging data generated during the course of a clinical trial. Our expert technicians use innovative tools to deeply review, update, and assure compliance with clinical trial protocols and defined reading paradigms. This enables queries to be issued, tracked, and resolved. Our ICL collection management process is designed to detect early on any substandard image quality or violations of the imaging protocol.

Our imaging core lab collection management process includes:

  • Collect image data
  • Query sites for missing data
  • Translate/digitize image data
  • Image QA/QC
  • Image data query resolution
  • Archive for long-term storage
  • And more

Quantitative analysis backed by scientific expertise

We provide expert independent review of liver images and quantitative image analysis using our team of radiologists and state-of-the-art software to deliver reproducible, high quality data.

Network of Key Opinion Leaders (KOLs)

As an industry leader in imaging core lab services, Bioclinica has long-standing relationships with a vast network of academic and research key opinion leaders (KOLs) who are available for image review, quality assessment, and imaging charter support. Our KOLs are well recognized for their NAFLD/NASH expertise and provide an additional resource for sponsors planning NAFLD/NASH trials.

With Bioclinica, you'll receive powerful, comprehensive reporting services for sites and sponsors, which supports the management and review of data for clinical trials.

Gain access to real-time reports, such as:

  • Eligibility and safety reports

  • Metrics reports

  • Project status reports

  • Custom client reports

  • Analysis results reports

  • Billing reports

Bioclinica's transfer tools support a wide range of formats to meet client and project specifications — tools that enable clinical trial data delivery, including patient data and imaging data, to sponsors, external vendors, and partners.

LEARN MORE ABOUT THE SMART PROCESS

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ADDITIONAL RESOURCES

STATE-OF-THE-ART DETECTION & ASSESSMENT OF NAFLD/NASH USING MEDICAL IMAGING

Download Brochure

HOW TO IMPROVE NASH ELIGIBILITY SCREENING & GAIN INSIGHT INTO THE EFFECTIVENESS OF YOUR INTERVENTIONS WITH IMAGING

READ BLOG

SMART: A FULL SUITE OF CENTRALIZED MEDICAL IMAGING TRIAL SERVICES

DOWNLOAD INFOGRAPHIC

Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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