● Generate tables, listings, & figures for
interim and final analyses for clinical
studies, including DSMB/DMC
● Support sponsor & regulator reviews of
statistical output
● SDTM
○ Create SDTM from EDC, lab, coding,
& other data
○ Track data issues
○ Perform Pinnacle21 validation
● ADaM
○ Create AdaM from SDTM for safety
and efficacy analyses
○ Perform Pinnacle21 validation
● Develop fully compliant CDISC
NDA package
● Perform e-submissions of data or
support for regulatory body review