Statistical Consulting
• Protocol development including novel and complex trial designs
• Power and sample size assessment
• Regulatory submission strategies
• Exploratory analyses for corporate or scientific support
DMC/DSMB
• Prepare and/or review DMC Charter and interim analysis plan
• Coordinate and manage administrative and data review meetings
• Perform statistical analysis (blinded and/or unblinded)
• Lead open/closed session meeting and prepare meeting minutes
• Support post-meeting follow-up and ad hoc requests
Statistical Analysis
• Statistical Analysis Plan (SAP) and mock-up Shell
• Tables, figures, and listings for CSR
• CDISC database standardization
• Supportive analysis for publications, abstracts, presentations, etc.
• Patient profiles
Randomization
• Generate randomization specification, dummy randomization list, and live randomization list
• Prepare emergency unblinding envelopes
CDISC: SDTM and ADaM
• Prepare programming specification & define files for SDTM and ADaM
• Generate SDTM and ADaM domains
• CDISC compliance check
CRO Management and Oversight
• Seamless integration with your statistical team
• Review of statistical documents and deliverables