Biostatistics
Statistical expertise delivered directly by our in-house biostatistician, from study design support to statistical interpretation.
The challenge
Statistical decisions shape a study long before any data are analyzed: the design, the endpoints and the analysis approach all determine what a trial can show. When statistical input arrives late or sits apart from the development team, important decisions are made without it.
Biostatistical services are performed directly by SINUA within the scope agreed for each engagement. Any related activity outside that scope is identified and agreed separately with the sponsor.
Scope of support
- Clinical trial statistical planning
- Study design support
- Statistical methodology
- Statistical analysis planning
- Biostatistical analysis
- Statistical interpretation
- Statistical input into study documentation and development decisions
Key deliverables
- Statistical input to protocols and study documentation
- Statistical analysis plans
- Statistical analyses and interpretation within the agreed scope
- Statistical input to development decisions
Expected operational benefits
- Statistical thinking built into design decisions from the start
- Consistent interpretation across documents and decisions
- Clear statistical accountability within one team