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Tumor Assessment Using RECIST 1.1 Criteria and Alternative Criteria for Immuno-oncology Trials

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White papers

Understanding Novel Response Patterns of Immunotherapies

Immunotherapies display novel response patterns that affect the design of imaging based studies and the subsequent evaluation of imaging data. Applying traditional chemotherapy-based response assumptions to immunotherapy trials can result in inaccurate interpretation of response, premature therapy termination, and unnecessary removal of subjects from a trial. Our unique solutions for medical image analysis and management and iBiopsy® for imaging phenotyping, together with our global team of experts, are advancing the development of new drugs and diagnostic tools to monitor disease and assess response to therapy.

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Case studies

How automation can improve data consistency/value, and streamline study workflow

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Scientific publications

Emerging technologies and their impact on regulatory science

Elke Anklam [1], Martin Iain Bahl [2], Robert Ball [3] et al. - Affiliations: [1] Joint Research Centre, EU. [2] National Food Institute, Technical University, Denmark. [3] U.S. Food and Drug Administration.

This scientific paper was published in Experiment Biology and Medicine Journal and led by the U.S. Food and Drug Administration. It summarized selected presentations from the Global Summit on Regulatory Science (GSRS20), and highlighted the importance for regulatory community to work closely with the technology developers for emerging global regulatory challenges. Dr. Yan Liu (MD and PhD), Chief Medical Officer at Median Technologies was selected to participate in the elaboration of this paper.

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