Statistical Programming
SDTM Programming
- Develop SDTM datasets for ongoing studies
- Convert databases to SDTM standards
- Map raw data variables to SDTM domains
- Create SDTM specification documents
- Program SDTM domains
- Validate SDTM domains
ADaM Programming
- Map SDTM data variables into ADaM domains
- Map raw dataset into ADaM domains
- Create ADaM specification documents
- Determine derived variables for analysis
- Determine analysis flags (population, sub-group) need for analyses
- Program ADaM Domains
- Validate ADaM domains
TFL Programming
- Create TFLs based on shells created from the SAP
- Interim & Final CSR analyses
- Annual safety updates/DSURs
- Summary of clinical safety/efficacy (SCS/SCE)
- Integrated summary of safety/efficacy (ISS/ISE)
- Meeting abstracts or publication manuscripts preparation
- Ad-hoc & Post-hoc exploratory analyses
- Provide subset programs and outputs
- Validate independent TFLs programs