Medpace is excited to announce an agreement with Medidata to integrate imaging and clinical data into a single platform. Given the importance of imaging in today’s complex clinical trials, immediate availability of high-quality imaging endpoints in the study database is critical. Rave Imaging already provides image management support for a wide range of the clinical trial market place; providing electronic image capture for clinical trials. Integration with Medpace Core Lab’s (MCL) validated image analysis pipelines adds in-line quantitative analysis functionality capabilities. Along with support from MCL imaging scientists who have expertise across the entire spectrum of medical imaging from CT/MRI based RECIST measurements to liver fat fraction measurement and brain image segmentation. Clinical sites benefit from the support they receive from MCL’s imaging experts while experiencing the convenience of Medidata Rave Imaging for image data uploads and tracking. Sponsors benefit from the familiarity and reliability of the Rave Imaging interface. The integrated pipeline can now be used for defining eligibility, monitoring disease progression or response, making go no decisions, and providing quantitative end points.
“The MCL-Medidata partnership offers Sponsors seamless integration of quantitative imaging endpoints with clinical imaging trial management needed to meet modern regulatory requirements. MCL brings imaging expertise, a global network, and image quantification services together with the best in class data capture platforms offered by Medidata.” – Dr. Daniel O’Leary, Medpace Core Labs
MCL comprises a team of physicians, scientists, imaging technologist, image informatics experts and clinical trial management professionals that can provide high quality imaging endpoints for Phase 1-4 global trials. Our team has expertise in radiology, cardiology, medical physics, imaging technologies, image processing software engineering and site management. Through our partnership with Medidata as a preferred imaging provider, MCL is now able to provide seamless integration of our quantitative image analysis pipelines with Medidata’s RAVE Imaging© system and database. The combination of these tools produces the most powerful imaging trial management environment currently available to the clinical trial market. With RAVE Imaging available at sites for image data transfer and EDC functionality, integration with MCL’s pipelines provides quantitative analysis functions for imaging trials and data transfers to the sponsor without the need for 3rd party software. Together we are increasing efficiency and convenience by providing a single, familiar, image data management platform that aligns processes for expedited start up times and resource optimization.
MCL currently provides image quantitation functionality for MRI and CT data for estimation of MRI proton density fat fraction (PDFF), brain image segmentation and volumetrics using deep learning artificial intelligence methods, automated organ and muscle segmentation, oncology response evaluations based on RECIST 1.1, RANO and other criteria. The MCL scientific team can also customize and efficiently validate new image quantitation pipelines to provide sponsors with specific imaging biomarkers as needed and integrate them seamlessly with RAVE Imaging functionality. The integration of our quantitative imaging modules with Rave Imaging results in a seamless workflow in a single system, with no external data sources. Data quality and integrity are optimized. Imaging results are captured in the study database with a complete audit trail. MCL has been recently inspected by FDA and EMA without findings, providing further endorsement of the quality and validity of our clinical imaging trial process integration and traceability.
Together we are increasing efficiency and convenience by simplifying contracting for all clinical services. Our goal is to combine the most powerful systems, people, and processes to create seamless execution.