Blinded review, cross-functional input
Statistics sits at the same table as clinical and data management, keeping the blinded review comprehensive without crossing into unblinded territory.
What's included
What goes into meeting support
- Statistical findings from listings review summarized for discussion alongside clinical and data management input
- Outstanding data quality issues prioritized by their impact on key efficacy and safety endpoints
- Enrollment and randomization trend data brought in from reconciliation where relevant to the discussion
- Action items tracked back to data management, clinical operations, or edit check owners as appropriate
- Meeting notes archived alongside the broader data review record for audit traceability
Built on ongoing review, not a one-time check
Findings come directly from the recurring statistical data review process, not a separate review performed just for the meeting.