SMERUD’s biostatistical unit is responsible for study design, sample size estimations, randomization procedures, and for conducting the full statistical analysis of the study data in line with a pre-defined statistical analysis plan (SAP). We use the SAS® programme as our default system. Statistical programmers are responsible for the delivery of tables, listings and figures for the final study report.
Upon request, SMERUD will deliver according to the CDISC standards, using CDASH and/or STDM datasets and ADaM-based analysis datasets for the production of tables, listings and figures. CDISC is a required format for regulatory marketing authorization applications in the US, and recommended by EMA. However, many of our clients conduct only early clinical stage trials, such as phase 1 and early phase 2, which may not have registration purposes at the time being. Accordingly, such clients are looking for a lower-cost and less complex solution, which we can also provide.