The University of Colorado Bio-Imaging Research Laboratory (UC BIRL) provides image analysis and radiology review services for all clinical phases of drug development, ranging from small Phase I studies to large, international trials. Our services have been instrumental in the testing of new compounds, particularly in multiple sclerosis and the approval of Avonex™. The lab is composed of GCP and HIPAA trained professionals who have extensive training and experience in radiology, medical physics, computer science and clinical trials management. UC BIRL provides experienced project managers, interfacing with both sponsors and sites to ensure the timely receipt, review and reporting of quality data. The UC BIRL facility supports both film and digital data, with the ability to convert between the two. Fully digital (filmless) studies can be accommodated. 21 CFR 11 compliant systems allow UC BIRL to electronically receive, QA, process, and archive medical image data in a secure manner. Typical analyses include lesion counting and volumetrics, focal or whole-brain atrophy measures, serial registration, RECIST evaluation and lung histogram analysis. The laboratory also has the ability to process more complicated acquisitions, including diffusion tensor imaging (DTI), magnetization-transfer (MTR), and functional imaging (fMRI) using BOLD contrast. Custom data analysis for new or emerging biomarkers is available. UC BIRL prides itself on providing high quality site management, image analysis, and radiology review. Our on-staff radiology, medical physics, and technologist support ensure that trials are performed in a competent, technically sound, professional manner. Please contact us for more information regarding our services or to schedule a facility visit. |
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