Apparatus, methods and computer software products for clinical study analysis and presentation

An integrated clinical analysis database may include clinical data from observations of study subjects of a population of study subjects of a clinical study and metadata that defines a structuring of the clinical data that supports generation of a statistical analysis of the population of study subjects specified by study documentation of the clinical study. The metadata provides statistical variable definitions for the statistical analysis such that plural instances of the statistical analysis can be generated without determining new values for the statistical variables. Respective statistical analysis instructions may be accepted and, in response, the clinical study analysis database may be accessed and respective statistical computations may be performed using the statistical variables to generate respective instances of the statistical analysis. A user interface for presentation of the statistical analysis may be provided using, e.g., a web server. An integrated clinical study analysis database may include data and derivative data from study subjects, structured such that a statistic and/or a table value specified in documentation for the clinical study can be computed using published equations applied directly to existing values of variables in the database, and which includes at least two of: a dataset structured one record per subject; a dataset structure one record per visit per subject; a data structured one record per measurement occasion per visit per subject; and a dataset structured one record per event per subject.