C3 Research statistical team is able to support our clients through every step of the clinical development process by providing a full range of biostatistical services including:

• Optimal study design and sample size calculation
• Statistical methodology section for the protocol
• CRF review incorporating CDASH standards
• Randomization including stratification and adaptive techniques
• Statistical analysis plan (SAP) and associated output shells
• Annotated CRF reflecting SDTM data structure
• Specification and programming of CDISC-compliant SDTM and ADaM datasets
• xml for SDTM and ADaM datasets with associated Pinnacle reports
• SDTM and ADaM reviewer’s guides
• Dry run production of pre-database lock outputs for Sponsor review
• Datasets for external vendors
• Tables, listings and figures for the clinical study report (CSR)
• CSR statistical input and review
• Data Safety Monitoring Board (DSMB) Support
  • Serving as a DSMB statistician
  • Generating the DSMB Charter
  • Drafting DSMB mock tables and listings
  • Coordinating DSMB meeting arrangements
  • Programming, validating and reviewing the DSMB deliverables
  • Distributing open and closed DSMB reports along with executive summary
  • Presenting at DSMB meeting
  • Generating DSMB meeting minutes
  • Providing safety updates
  • Maintaining and archiving DSMB reports and documentation