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.
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?
Mock-ups tests for different assumptions and size effects. Analysis of the bibliography, writing of the rationale in the procedure.
It is crucial for a study to use optimum statistical methods for data analysis, while ensuring compliance with the agencies’ recommendations.
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...
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.
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.
MDSTAT Consulting, CIR approved since 2011