Biostatistics

Julius Clinical Research executes its Biostatistics services through the academic department of Biostatistics within the Julius Center. Under leadership of Professor Kit Roes, the department combines strong clinical research experience with the full benefits of an academic research setting. Hence, they can provide expert input in clinical research design, statistical analysis plans and perform protocol based statistical analyses. Typically top line result will be reported, as well as key secondary analyses, both for the associated scientific publications as well as the clinical study report. Depending on sponsor requirements full ICH compliant analyses and reports can be delivered. Julius Biostatistics is also well positioned to provide independent statistical analyses for pivotal or high profile clinical trials and act as statistical coordinating centre for interim analyses and Data and Safety Monitoring Boards. Successful examples include the CONTRAST, EUFEST and ADVANCE studies referred to in our Study Design overview.