SPECIALIZED AREA
Post-marketing & real-world studies
Biostatistical and programming support for studies that evaluate safety, effectiveness, utilization and outcomes after launch.
Support can be provided for individual analyses or as an integrated work package spanning planning, data review, analysis and reporting.
Study types
- Phase IV studies
- Observational studies
- Registries
- Real-world data and evidence analyses
Statistical support
- Study design and sample size
- Statistical Analysis Plans
- Safety and effectiveness analyses
- Subgroup, sensitivity and longitudinal analyses
Programming & reporting
- Analysis datasets and TLFs
- Patient-reported outcome analyses where specified
- Statistical reports and interpretation
- Reproducible updates for recurring analyses
Delivery model
Engagements can be fixed-scope, milestone-based or ongoing, with sponsor-specific data access and privacy requirements built into the delivery plan.