Our comprehensive statistical approach begins with discussions on statistical considerations required for the study protocol and end with statistical report, as well as writing the final report.       Highlights           Patient sampling plan Endpoint development, trial size & duration Interim analysis plan (IAP) Randomization Statistical analysis plan (SAP) SAS production of table Listing, & figure displays for use in study reports or other summary activities IAP incl. coordination with DSMB Stand alone reports Final integrated clinical reports (GCP-ICH) Ad hoc analysis