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Research:
Strategies for a Successful Imaging Review
Poll: Is a lack of CRAs affecting the growth of the industry?
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"Facts are the air of scientists. Without them you can never fly."
-Linus Pauling (Quantum Chemist and Biochemist, 1954 Nobel Prize Laureate in Chemistry, 1901-1994)
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Strategies for a Successful Imaging Review
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By Stephen W. Bates, Program Director and Nicholas R. Enus, Senior Project Manager, Medical Imaging & Diagnostics, Perceptive Informatics Inc., MA, USA |
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Medical imaging related endpoints in clinical trials are becoming increasingly important in supporting trial outcomes. Additionally, regulatory agencies seem to be increasing their acceptance of, and ultimately their absolute requirement for independent assessment of these imaging endpoints. However, many pharmaceutical companies and the CROs they employ are unfamiliar with the processes and procedures that must be implemented to support this new type of analysis. A successful independent imaging review requires proper planning and implementation all the way from protocol design to drug submission. |
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