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Any development plan is composed of multifaceted clinical studies which will set by successive stages, study after study, the therapeutic window dosage regimen and define the clinical specificity of the activity of the product evaluated compared to its competitors. Designing with ICTA a comprehensive clinical development or developing a simple clinical study is to benefit from a qualified and experienced, multidisciplinary team able to ask the right clinical questions, to make good methodological choices and to check the full feasibility of the study of interest within the timelines compatible with the defined objectives.
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ICTA’s Design department offers services based on an experienced and qualified R&D team who actively collaborates with a public-private network of experts from the academic and university teaching hospitals sphere.
Consulting in clinical design
Whether it is traditional, adaptive frequentist or Bayesian, the design of a clinical study moves through different steps starting with the formalisation of the rationale and ending with the development of a funding strategy.
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Formalizing the rationale
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Methodological choice
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Bibliographical studies
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Defining the primary endpoint
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Feasiblity study
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Risk analysis
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Sample size calculation
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Detailed drafting of protocol
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Defining the biostatistical analysis
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Drafting the study specifications
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Development of a funding strategy