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The analysis and reporting of a study represents the culmination of intensive planning and execution. A well designed study can still fail at this stage without sufficient investment of both time and resources engaging appropriate personnel. The inclusion of appropriately qualified and experienced biostatisticians in your clinical trial team is essential.
Careful consideration and a priori specification of who, when and how to analyse the results is a critical step to ensure the minimisation of bias and integrity of results.
Furthermore, the choice of which results to present, the form of presentation and interpretation are areas where many well thoughtout studies come unstuck.
At Statistical Revelations we can help you pre-specify the analytical approach, implement the plan to regulatory standards and work with your clinical team on appropriate presentation and interpretation either for an internal Clinical Study Report (CSR) or for publication in peer reviewed journals.