We understand the global regulatory requirements and we can provide you with:
- Statistical consultancy in the protocol design stage
- Sample size determination/power calculation
- Writing the statistical section of the protocol
- Development of the statistical analysis plan, including tables, listings and figure shells
- Preparation of randomisation lists
- Centralised randomisation/minimisation
- Blind review of data including pre-analysis discussion with project team
- Safety reporting/ Safety Committee meetings
- Interim analysis/ Final statistical analysis using SAS®
- Statistical and integrated study report writing