Quantitative imaging has the potential to transform cancer research and diagnostics. The National Cancer Institute recently funded the Integrative Imaging Informatics for Cancer Research (I3CR), a 5?year grant at Washington University School of Medicine to develop advanced imaging informatics technology to enable this transformation. I3CR provides a range of imaging informatics capabilities to enable quantitative imaging in cancer research, including tools to integrate image acquisition, analysis workflows, phenotypic and genomic data sources, and clinical information and treatment systems. This SBIR project will develop an FDA compliant version of this platform suitable for industry use in clinical trials and patient care. The first project objective is to develop a cloud?hosted version of the I3CR platform that incorporates Radiologics? existing regulatory compliance software modules including audit trails and electronic signatures. The second project objective is to implement regulatory compliance infrastructure to achieve full FDA compliance for clinical trials and patient care. The work will be performed by Radiologics personnel with expertise in the XNAT and I3CR systems, FDA regulatory systems, and cloud hosting and operations. The Radiologics team will be bolstered by partnerships with the I3CR investigators at Washington University and regulatory consultants with expertise in all aspects of FDA compliance.
