IMAGING CORE LAB: FULL-SERVICE IMAGING

FOR CLINICAL STUDIES EXPERTS Medpace Imaging Core Labs (MICL) combines state of • Integrated team of technologists, the art imaging services with Medpace clinical teams physicians, and medical physicists with to provide efficiency through partnership. Medpace clinical trial experience delivers effective collaboration, training, and resource • Board certified radiologists with extensive planning around the globe with consultation on imaging experience as independent readers in biomarker strategy for clinical development plans clinical trials across therapeutic areas. Working closely with top • Imaging physicists and computer scientists therapeutic experts, our proficient and experienced with advanced knowledge of medical image team members engage quickly and provide strategic acquisition and analysis methods. thinking to ensure quicker start-up times, superior quality, and the most efficient delivery at every phase EXPERIENCE of your trial. • Recommendations for imaging- related components of clinical trial protocols, and MICL provides an end-to-end suite of global imaging informed consent services and modalities to enhance and expedite • Cloud-based image and clinical trial biopharmaceutical and medical device development management using ClinTrak® Imaging system across therapeutic areas. MICL partners with imaging – 21 CFR Part 11 and GDPR compliant experts from major academic and clinical institutions – Site image transfer and tracking that have experience in clinical trials research and have – Integrated QC/QA processes integrated these activities into their daily work-flow to – Real-time resolution of quality issues provide timely, expert readings. Readers and imaging – Information continuously available to trial medical experts drawn from these institutions Sponsor enable MICL to provide a customized experienced • Images processed and archived following reader network for your study. Medpace Core Labs SOP MICL uses registered radiological technologists with EXECUTION experience qualifying sites for novel image acquisition • Standardization of image acquisition protocol protocols. Medpace has imaging Project Managers across global sites who specialize in managing global, imaging-focused • On-site or web-based training (multilingual) trials. This dedicated staff is trained on all imaging • Continuous QA/QC to ensure consistent image components of a clinical trial including site selection. quality and adherence to imaging protocol Global site selection is an important part of any study, • De-identification of incoming image data and MICL has a proven process including evaluation of • Study specific manuals for acquisitions at sites on-site imaging equipment, identification of qualified and central reviewer procedures on-site imaging staff, and site qualification to confirm • Imaging Review Charter as recommended imaging. by FDA • Secure GDPR compliant data management • Complete audit trail

IMAGING SERVICES FULL-SERVICE STUDY DESIGN ClinTrak IMAGING INTEGRATION AND MANAGEMENT Integrated with ClinTrak, the Medpace clinical trial management system, ClinTrak Imaging consists of • Design and implementation of centralized leading edge technologies to track, interpret, and independent review/analysis of images communicate imaging and related data in the most • Defined in the Imaging Review Charter timely and secure manner possible. Featuring an • Design of imaging related eCRFs for the central intuitive, web-based interface, ClinTrak is designed image QA/read/analysis results to integrate all components of the trial and provide • Creation ClinTrak Imaging - database for image access to study data and metrics. analysis results • Data management of imaging results ClinTrak Imaging is an MICL developed application (ClinTrak Imaging) with web−based front−end and robust SQL−server • Efficient, web-based transmittal and analysis back-end. ClinTrak software runs on Medpace owned of images allows rapid turn–around for time- and operated, redundant hardware, ClinTrak Imaging sensitive imaging criteria, such as eligibility provides real-time central tracking, data management, and safety quantitative and qualitative analysis, and image- • Data transfer specification document, and related reporting information. scheduled data transfers • Statistical analysis of imaging results Features include: • Generation of report for imaging component • SecureMake username/password the Complex access Seamless of study • Image/scan tracking and archiving • Seamless integration with other study- • De−identificationwith a Global, Full-Service CRO related services • Data management/query resolution and tracking • Seamless database integration with clinical • Customized eCRF for entry of image analysis data database regulatory submission preparation • Image analysis results database • Real−time web−based status reporting INDEPENDENT IMAGE REVIEW • Audit trail MICL can provide independent, blinded, central, • 21 CFR Part 11 and GDPR compliant readings of clinical trial images from a pool of over 200 board certified, subspecialty trained radiologists, FULL-SERVICE CLINICAL DEVELOPMENT cardiologists, and other specialists. MICL central readers work in a secure, online environment Medpace is a scientifically-driven, global, full- using certified software and workstations service clinical contract research organization (CRO) integrated into ClinTrak Imaging, allowing for providing Phase I-IV clinical development services prompt turnaround and continuous oversight. to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate Our readers have extensive clinical trial experience the global development of safe and effective medical with cardiovascular, central nervous system, therapeutics through its high-science and disciplined musculoskeletal, oncological, metabolic, and operating approach that leverages local regulatory pulmonary diseases, as well as interventional and and deep therapeutic expertise across all major areas medical device studies. Our imaging expertise including oncology, cardiology, metabolic disease, includes MRI , PET, CT, angiography, ultrasound, echo- endocrinology, central nervous system and anti-viral cariography, DEXA, endoscopy, photography, ocular and anti-infective. CT, and advanced image analysis and rendering.

MCL-0005-0519