Nereďs Dévelopment This entity will have as its mission, to use the chain of active expertise of the pre-clinical development in the phases II and III of clinical development. Both for the molecules coming from its own research and for the molecules or methodologies coming from an external research; the latter also includes private research as well as public research. The competences of this entity, at the same time through their complementarity and through their management and their harmonisation, constitute an incontestable and unique increment in such a structure, clearly distinguishing it from a simple CRO service type company

 

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Clinical pharmacology of phase I  

The role of this unit essentially consists of research of usable doses and of research in pharmacokinetics of products after administration, generally, unique. These first administrations realized on healthy volunteers are based on the results of animal toxicology and of pharmacology legislation and therefore have as their objective to determine the potentially active doses, well tolerated by man. This research must lead directly to the writing of clinical pharmacology reports directly usable by the registration authorities.The experience of this unit in fields as varied as anti-infectious, illnesses of the bone, endocrinology, the cardiovascular, the central nervous system, immunology and recombinant proteins, demonstrates the wide spectrum of competence of the personnel in this unit

 

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Clinical tests phases II and III  

This service must permit the development and lead to the registration of the molecules which are assigned to it. It must ensure the writing of the development plans by its medical expertise, in contact with the registration authorities, put in place and motivate all the research of phase Iib and III via networks of physicians and CROs and to write the necessary reports. The key strenghts of the teams, which constitute this sector, consist in the deep knowledge of regulatory obligations of the EMEA (European Medicine Agency) and of the FDA, in its experience of projects on a large scale at multiple sites, as well as work in varied therapeutic fields

 

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