MacroStat provides services for protocol development, sample size calculation, database setup, case report forms design, data management, statistical analysis plans, CDISC SDTM/ADaM and analysis datasets generation, SAS programming, data and safety monitoring board (DSMB) support, integrated summaries of efficacy (ISE) and safety (ISS) for new drug applications (NDA), clinical and statistical reports, and NDA submissions to the regulatory agencies worldwide.