Preclinical data needs to be adequately documented to allow translation into a clinical study by complying with all medical, scientific, ethical and regulatory aspects. Historical cases have shown that bridging preclinical and clinical has not always been easy due to lack of focus on the necessary level of quality assurance. The gap needs to be understood first and then strategies need to be developed to enable a smooth translation of the preclinical data of “research in animals” to the clinical research with First in Human studies.
Medace strives to implement quality as the leading parameter early on in order to guarantee a smooth translation later in the process. Starting early with quality minimizes the risk of having to repeat costly experiments later on in the process.
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