Our ISS ISE services support you with the analyses of data from more than one study by pooling subject-level data or pooling common outcomes from individual studies and comparing results. We will help you demonstrate evidence of effectiveness across different sub-groups such as demographic characteristics such as sex, age and racial sub-groups and other relevant sub-populations like patients with different levels of severity of disease. This includes the strength of statistical evidence from the consistency of the findings across individual studies especially for pre-specified primary endpoints. Any important differences in outcome need to be discussed and displayed and if possible, factors underlying the differences be identified. At Quanticate, we are able to use our statistical tools to help identify inconsistencies across studies and underlying factors associated with these differences. We will describe key statistical issues and findings that impact the demonstration of efficacy and/or safety based on each study and on the collective evidence.