Analysis of needs and expectations of customers Proposition of an adapted and relevant solution which takes into account:
The objectives of the laboratory (marketing, new indication, better location of a product…)
The feasibility of the study in terms of financial, human and logistic means
The regulatory strategy with the aim of the exploitation of the results
Expert consultation:
Request of the national and international network of experts of Qualissima
Synopsis:
Synopsis development after consultation of experts' network
Sponsor assistance with Health Authorities
Selection of the Scientific Committee of the Study:
Recommandation/sollicitation/coordination of the scientific committee ad hoc of writing of the protocol consisted of specialists of the studied pathology, methodological and statistical experts, coordinators of clinical studies, experts of the regulatory aspects.
Discussion and validation of the research protocol and the CRF elaborated by Qualissima.
