●The Protocol Design
●Consultation on Statistical Methods
●Sample size Calculation
●Randomization scheme
●Drugs Blindness
●Statistical Analysis Plan
●Statistical tables, Listings, graphs
●Statistical Analysis Report
●CRF Annotation
●Create SDTM Dataset
●Create Analytical Dataset (Adam)
●CDISC Standardization Review
●Data Standardization Verification Based on Pinnacle 21
●Data Quality Verification, PD Verification
●Create Table, listings and figure outputs
●Data E-submition