Overview of clinical data management and statistical analysis of bioequivalence study

Kala N. G., O. Shruti, Aishwarya B. M.

Abstract

Owing to the demands of both pharmaceutical industry and the regulatory authorities’ clinical data management (CDM) field came into practice. CDM plays a vital role in the study data gathering stage of clinical research. In order to meet this goal, specialized tools i.e. software applications are used to maintain audit trials that offer easy identification and resolution of data discrepancies even in huge and complex clinical trials. Hence a proper and effective clinical data management is required for generating high-quality, accurate, reliable and statistically sound dataset. Such dataset are relatively easy to interpret which is a key step in statistical analysis of a bioequivalence study. Performance of a thorough analysis is dependent on the quality of the trial data. This review highlights how data is processed after it is captured through eCRF, data validation, data cleaning and statistical analysis specially focused on Bioequivalence studies.

Keywords

Clinical trials, Case report form, Edit checks, Pharmacokinetics, Bioequivalence

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References

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