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Test and Refine
Verify prototype performance with bench or laboratory testing to show that it does what is intended.
End-user studies are then needed to confirm the acceptability and usability of your solution. To provide this proof, the clinical trial design must consider safety, feasibility, target population, key endpoints, sample size, data collection, and statistical analysis. You will also need to obtain ethics and locality approval for studies conducted in human volunteers/patients.
For clinical trials conducted in Aotearoa New Zealand, Medsafe offers a range of information.
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