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