Biostatistics

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