FDA COMPLIANT IMAGING INFORMATICS FOR CANCER RESEARCH

Quantitative imaging has the potential to transform cancer research and diagnostics The National Cancer Instituterecently funded the Integrative Imaging Informatics for Cancer Research I CR a year grant at Washington UniversitySchool of Medicine to develop advanced imaging informatics technology to enable this transformation I CR provides arange of imaging informatics capabilities to enable quantitative imaging in cancer research including tools to integrateimage acquisition analysis workflows phenotypic and genomic data sources and clinical information and treatmentsystems This SBIR project will develop an FDA compliant version of this platform suitable for industry use in clinicaltrials and patient care The first project objective is to develop a cloud hosted version of the I CR platform thatincorporates Radiologics existing regulatory compliance software modules including audit trails and electronicsignatures The second project objective is to implement regulatory compliance infrastructure to achieve full FDAcompliance for clinical trials and patient care The work will be performed by Radiologics personnel with expertise in theXNAT and I CR systems FDA regulatory systems and cloud hosting and operations The Radiologics team will bebolstered by partnerships with the I CR investigators at Washington University and regulatory consultants withexpertise in all aspects of FDA compliance