Clinical Evaluation Strategy
A clinical evaluation strategy outlines the strategy to gather clinical evidence supporting device safety and efficacy. Essential elements are:
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defining objectives and device's intended use
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thorough literature review to identify similar devices and gather relevant clinical data
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plan and design well-controlled clinical investigations
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identifying target populations
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establishing measurable endpoints
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evaluate device performance and adverse events
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address safety concerns or usability issues
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calculating sample sizes
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planning data collection and analysis
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ensuring ethical and regulatory compliance
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Services
QMedCo provides strategic advise:
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on all mentioned essential elements of clinical evaluation strategy
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determine the required amount of qualitative and quantitative data to ensure the delivery of robust clinical data
- to setup an approach for Clinical Investigations with cost efficiency & cost effectiveness as priority
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