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What
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Clinical Study Design
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Clinical
studies are designed to prospectively incorporate
imaging endpoints as part of overall study design
to enable comprehensive and cost-effectively mining
of the wealth of quantitative information available
in medical imaging. If drug efficacy or product mechanism
of action relies on medical imaging as proof, it is
essential that this imaging be accurate, appropriate,
and accepted by regulatory agencies as a surrogate marker. |
Management
Services
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Source
imaging centers with sufficient expertise tailored
to study needs |
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Develop
imaging QA measures for data acquisition |
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Source and negotiate imaging core lab contracts , manage outsourcing of imaging data evaluation to
core laboratories, blinded reads, quantitative measurement
collection |
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Product Development Troubleshooting
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Review
of available clinical trial data |
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Strategic
implementation of advanced medical imaging tools (retrospective
blinded reads, single study imaging-intensive prospective
trials, improving imaging concepts in ongoing trials,
etc.) |
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