Statistical Programming Service
- Study data tabulation model (SDTM) datasets
- Development of analysis datasets (ADaM)
- Tables, listings, and figures (TLF)
- Submission-ready datasets, programs, specifications and define.xml
- Integrated summary of safety & efficacy (ISS/ISE)
- Database edit checks, query creation, patient profiles and other ad-hoc reports
- DMC support, Interim analysis, DSUR, PSUR and safety surveillance & publications
- Statistical method development, simulations, sample size calculations, and exploratory analysis