Reproducible Reporting
Mats Magnusson, Niclas Jonsson
Pharmetheus
Reproducible Reporting
Pharmacometrics in Phase III analyses poses unique challenges such as short time lines, large data bases, multiple end-points, integration of old and new models, as well as extensive reports, formatted according to company and regulatory requirements. However, in a recent Phase III population PK analysis, Pharmetheus supported a project with a 7 weeks turnaround from final analysis data set to submission. This was made possible by careful planning, dummy data and report, mock review and QC, and simulations to prepare for different study outcomes. The 7 weeks were spent on data analysis activities, not report editing, which led to well grounded conclusions and high scientific quality. This would not have been possible without the Reproducible Reporting environment used at Pharmetheus. Meet us in the exhibition area and let us demonstrate how this was done.
