HEPATOLOGY (NASH/NAFLD)
NASH/NAFLD Imaging Expertise
For more than 20 years, WorldCare Clinical has been a leading provider of imaging services for Hepatology (NASH/NAFLD) clinical trials.
Experience Across Hepatology Indications
Our team has provided imaging CRO services on dozens of Non-Alcoholic Steatohepatitis (NASH) &
Non-Alcoholic Fatty Liver Disease (NAFLD) clinical trials. Our dedicated team of researchers and clinicians have extensive experience in hepatology and advanced quantitative analysis of MRI images. In addition to our experienced staff, we work with a team of independent board-certified, and subspecialty trained radiologists who have clinical and research experience in NASH & NAFLD and have worked with us on global hepatic imaging trials.
Modalities
- MRI-PDFF
- MRS (with fat quantification)
- MRE (elastography)
- DXA
- Region of Interest volumes in the liver
Read Team
Our dedicated team of radiologists, technicians, regulatory experts, and project managers is among the most knowledgeable and well-respected in the industry. Our services also include safety monitoring. Our services also include safety monitoring. experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.Modalities
Through a combination of our expert radiologists and our rigorous training and testing regimen, we are committed to increasing the accuracy and precision of data subject to blinded independent central review. Sponsors have the flexibility of working with our highly-trained in-house radiologists, with sub-specialty-trained board-certified radiologists from the Harvard Hospital System, or with other radiologists of the sponsor’s choice.
Study Design
Our experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.
Web-Based Technology Platform
Our state-of-the-art systems are 21 CRF Part 11 compliant and are used to analyze images from all modalities. The systems can be accessed by radiologists to perform assessments anywhere in the world. Thousands of clinical sites in the U.S., Latin America, Europe, and Asia-Pacific have uploaded imaging data directly into our secure system.
Regulatory Experience
We have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) Medical Imaging Division and the European Medicines Agency (EMA). Our Quality Management System is designed to provide the structure and controls required to support execution of the clinical study, while ensuring that processes meet current regulatory standards.