Biostatistics
Biostatistics Service
- Study design and protocol development
- Sample size calculations
- Statistical methods for protocols
- Randomization schemes
- Statistical analysis plans (SAP)
- Study result interpretation
Strategic Consulting Service
- Reviewing literature, NDAs, and competitors data
- Consulting in adaptive design strategy
- Forming and severing in Data Monitoring Committee (DMC)
- Conducting exploratory data analysis of existing studies
- Performing integrated analyses for Integrated Summary of Safety and Efficacy (ISS/ISE)