The determination of sample size in a medical device clinical trial requires comprehensive understanding in the related medical field, study design, statistical methodology, information collected on the subject device, threshold established for alternative treatment modalities, country-specific regulation, overall global regulation, etc. BradyKnows will assess all available information on the investigational product and work closely with PIs and statisticians to develop a reasonable and justifiable sample size for your planned study in China.
Takeaway: Sample size determination is a complex process that requires input from multiple professional areas.
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