Biostatistics
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More Than Statistical Analyses
A Deep Understanding of Every Aspect of Clinical Development Programs:
- Clinical development planning
- Study design and protocol input
- Randomization schedule development
- Statistical Analysis Plan (SAP) and TFL Shells development
- Data Monitoring Committee, Evaluation Committee and Interim Analysis support
- Integrated summary of efficacy and safety (ISE/ISS)
- Statistical analysis report
- Regulatory agency interactions and submissions support
- Publication support and ad hoc analyses
- Statistical consulting
Insight
