● Specialized services supporting Sponsor's
development and regulatory strategy,
including:
○ Statistical design
○ Protocol consultation
○ Attending/supporting review meetings
with regulators
○ Communicating with regulators on behalf
of sponsor about protocol revisions,
efficacy endpoint changes,
statistical methods, etc.
○ Serving on DSMB/DMC
● Sample size calculation
● Statistical Analysis Plan & Statistical
Analysis Report
● Blinded data review
● TFL shell design
● Interim analyses
● IND & NDA/BLA submissions
● Reporting, including CSRs, manuscripts,
abstracts, & presentations
● DSMB/DMC