Device, technology, method or drug
First-in-Human (FIM) trials are premarket investigations on human subjects to provide objective clinical evidence to assess the intended efficacy of a novel product applied to humans.
All FIM studies require formal approval from Regional Ethics Committees including informed and written consent from research subjects enrolled. A FIM trial may or may not include compliance to formal regulatory requirements. Clinical evidence in FIM studies may include expert opinion and advice, reviews of clinical literature in addition to prospective trials. Nordic Proof offers single-centre or multicentre FIM studies involving one or more partners in the Nordic capital regions.
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