Determining Critical Study Endpoints
Complex studies demand full service core imaging services. The ability to conduct global studies using innovative core imaging techniques and imaging technology to determine critical study endpoints is a challenge.
Medpace Imaging Core Lab provides an end-to-end suite of global imaging services to enhance and expedite biopharmaceutical and medical device development across multiple therapeutic areas utilizing appropriate imaging modalities. We partner with imaging experts from major academic and clinical institutions involved in research. These experts have worked on numerous pharma- and device-sponsored studies for many years and have integrated these activities into their daily workflow to provide timely, expert readings. In addition to readers, our imaging trial medical experts are drawn from these institutions allowing us to provide a customized, experienced reader network for your study.
Independent Centralized Image Readers
Medpace Imaging Core Lab provides blinded central readings from a defined pool of more than 200 board certified, subspeciality trained radiologists, cardiologists, and other specialists. Our readers work in a secure environment utilize identical software and workstations integrated into our proprietary ClinTrak Imaging IMES system, allowing for prompt turnaround and continuous oversight.
Our readers have extensive clinical trial experience with cardiovascular, central nervous system, musculoskeletal, oncological, endocrine, gastrointestinal, and pulmonary diseases, as well as interventional and medical device studies, utilizing imaging modalities such as CT, MRI, PET/CT, 3D volumetric analysis, ultrasound, DEXA, angiography, endoscopy, and photography.
- Preparation and recommendations for imaging-related components of the clinical trial protocol, ICFs, and CRFs
- Coordination with Sponsor/clinical CRO on global site selection to ensure that sites have access to imaging capabilities needed for the trial including on-site equipment evaluation and on site imaging staff selection
- Site qualification to confirm imaging quality and proper imaging equipment calibrations prior to trial subject scanning
- Imaging Review Charter to define imaging acquisition, data management, and image analysis procedures
- Standardization of image acquisition protocols across global sites
- Study specific staff training via technical manual or web-based
- Training of clinical trial CRAs for imaging components of trial
- Centralized collection and archival of images from sites globally via web to ICL servers or courier to office
- Tracking and quality control/assessment of image data using the ClinTrak® Imaging system
- Proper image de-identification and adherence to imaging protocol
- Real-time feedback to sites on quality issues
- Proprietary 21 CFR Part 11 compliant software
- Complete audit trail including Secure server back-up for all images and image analysis data