Comprehensive Statistical Consulting and Management Services
We ensure your design supports your clinical development journey by:
- Providing sample-size justification with sensitivity analyses
- Comparing candidate designs with what-if simulations and decision rules
- Determining how patients are assigned and balanced (randomization/stratification)
- Delivering data quality oversight using statistical monitoring and centralized review
- Choosing the right approach for the question, such as frequentist vs Bayesian or fixed vs adaptive design
- Delivering data quality oversight using statistical monitoring and centralized review
- Creating PK/PD, observational, and real-world evidence designs
- Providing regulatory consults (FDA, EMA, Health Canada)
- Delivering CDISC (SDTM/ADaM) standards guidance and program-level strategies
- Training non-statisticians, so teams can act on the plan
Deliverables to Guide Your Program
We also provide recommendations, key risks, next steps, and materials you can share with leadership, including:
Documentation
Redlines to the protocol or statistical analysis plan (SAP) and mock shells for key TFLs
Simulations
If we run simulations, you get a summary of all assumptions and results
Analysis & reporting
When it’s time to close out the study or perform an interim analysis, we help with results interpretation and write-ups
