Biostatistics Service
- Statistical analysis plans (SAP)
- Protocol, case report form (CRF), clinical study report (CSR)
- Table listing figures shell (TFL shell)
- Randomization schedules
- Statistical modeling/exploratory analysis
- DMC support, interim analyses support and other periodic reporting
- Integrated analysis (ISS/ISE)
- FDA and other regulatory interactions
- Publication support and ad hoc analyses