At Resolutum Global, our biostatisticians are engaged through the life of the project from study design to finalization of the clinical study report. We can also provide consulting services based on your project’s requirements.

During the study design phase, our biostatisticians can provide input on the following areas:

  • Study design elements

  • Selection of the patient populations

  • Identification of study endpoints and statistical analysis methods

  • Sample size calculations

  • Study randomisations.

During the project, our biostatisticians provide the following services:

  • Development of the statistical analysis plans (SAP) and output shells

  • Provide data and analysis to support DSMBs, Data Monitoring or Safety Review Committee Meetings, Development Safety Update Report and interim analyses

  • Statistical analysis and review of all statistical deliverables

  • Ad hoc, post hoc and exploratory analyses.

  • Development of the statistical report and/or input to the clinical study report.