At Resolutum Global, our biostatisticians are engaged through the life of the project from trial design to the finalization of the clinical study report. We also provide consulting services based on your project’s specific requirements.
During the trial design phase, our biostatisticians provide input on the following areas:
- Trial design elements.
- Selection of the patient populations.
- Identification of trial endpoints and statistical analysis methods.
- Sample size calculations using PASS Sample Size.
- Trial randomisations.
During the project, our biostatisticians provide the following services:
- Development of the SAP and output shells.
- Analysis to support DSMBs, Data Monitoring or Safety Review Meetings, Development Safety Update Reports (DSURs) and interim analyses.
- Determination of analysis populations.
- 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.
Our team supports clients with ad hoc and post hoc analyses, providing a more flexible and pragmatic approach to data analysis compared to their other vendors.
We also have the capacity to support and participate in Data Safety Monitoring Board meetings.