Controlled prospective or randomized
Nordic Proof offers sponsors clinical trials on representative populations to understand and verify the ultimate effect of new products and obtain regulatory approval.
Clinical trials includes follow-up of enrolled subjects spanning many years. All clinical trials require formal approval from Regional Ethics Committees including informed and written consent from research subjects enrolled. Considerations for clinical trial design are based on the intended use of the product, the end user population, the effect of the product, complexity of product use and the anticipated outcome. Nordic Proof partners offer a broad variety of clinical trial options depending on device category, intended use and end user population.
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