Statistical Analysis

For most Clinical plans or large post-marketing observational studies there is a need to utilize statistical software packages in order to know how many patients are required in a study in order to demonstrate product equivalence, superiority, statistically significant differences and confidence levels of those differences. Above the software packages themselves are the statisticians who know what types of studies require which type of analyses in order that the correct statistical approach has been applied.

Such a person is vital either in scientific pre-discussions with Regulatory Agencies concerning the type of analysis or understanding of the size of patient recruitment to demonstrate what the Regulators would like to see. Their expertise is critical to the success of the approval itself.