Consulting ›

The consulting services adapt perfectly to your workflow and according to the progress made in the studies. With MDSAT Consulting you have the advice of a biostatistician who is dedicated to you, knows your stakes and can challenge your CROs. Your final AMM will be of good quality, rigorous and consistent with the statistical strategies deployed following methodological advice provided throughout your development project. Thus, you are guaranteed to be in line with the latest regulatory developments and get support for meetings as well as responses to official documents.
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Consulting services for biotechnology and pharmaceutical laboratories

    Consulting and choice of experimental designs

    At the early stage of the study, it is essential to benefit from advices of a biostatistician, to identify the best criteria of effectiveness, how many actors will be needed and the number of visitors as well.

    Selection, checking and control of the randomization

    Randomization is essential for your clinical trial and a key element for regulatory authorities. At this stage, you must be supported by a biostatistician, in addition to your CRO, to secure and optimize this process as well as to answer these questions: Do you need to stratify or not? Why and how? What can you do in the event of an error of randomization?

    Assessment of the number of patients and power of the study according to different situations

    Mock-ups tests for different assumptions and size effects. Analysis of the bibliography, writing of the rationale in the procedure.

    Methodology drafting and statistical analysis of the procedure, choice of samples

    It is crucial for a study to use optimum statistical methods for data analysis, while ensuring compliance with the agencies’ recommendations.

    Support for results reporting (CSR, articles, ...)

    How far can we read into this assumption and how confident can we be? How to display the results in a smart way, with charts...

    Taking part into DMC, independent statistician job

    I have experience in being the member statistician of the DMC or the independent statistician in Phase III, international clinical trials in various therapeutic areas.

    Any other needs?

    In addition to consulting services, MDSTAT Consulting provides training offers too. These services enable you to have an overview and a deeper understanding of the main biostatistics methods. You will then be able to quickly assess the quality of the produced work and better understand study articles and reports.

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Crédit Impôt Recherche (CIR)

MDSTAT Consulting, CIR approved since  2011