Biostatistics
We provide purpose-specific biostatistical strategies and expert services for clinical trials and real-world studies, from design through analysis, interpretation, and regulatory submission.
Biostatistics with Academic Rigor
Robust statistics from study design to final analysis.
Biostatistics is a core ACRO capability. We turn clinical questions into evidence-based statistical answers. From sample size estimation to final analysis, we deliver statistical work that meets the needs of regulatory submissions and reimbursement assessments.
We combine academic methodology with practical execution. Analyses are prespecified, transparently recorded, and documented with auditability in mind.
Why it matters
Statistical quality determines whether trial data support clear conclusions or generate repeated regulatory questions. Prespecification, estimand definition, sensitivity analysis, and transparent handling of intercurrent events are essential. Omitting these steps may require additional responses during regulatory review and reimbursement assessment.
What we offer
Trial-level statistics
- Statistical Analysis Plan (SAP) development
- Sample size and power calculations
- Estimand framework definition under ICH E9(R1)
- Randomization design
Analysis and reporting
- Statistical analysis, primarily using R
- Generation of tables, listings, and figures (TLFs)
- Interim analyses and statistical support for DMCs
- Statistical report preparation
Specialized methods
- SAP-based statistical analysis — Survival, mixed-effects, longitudinal, and Bayesian methods
- Adaptive and group-sequential designs
- Network and pairwise meta-analyses
- Statistical analysis of real-world evidence (RWE)
How we work
Every project begins with the research question and regulatory pathway. We prespecify methods in the SAP, document assumptions transparently, and include sensitivity assessments. The result is statistical work prepared to withstand regulatory and reimbursement review.
Related services
- Protocol Development — Protocol scope and design choices inform the analysis plan.
- PK/PD Modeling — Pharmacometrics and biostatistics delivered by one team.
- Data Use & Regulatory Strategy — External control and indirect comparison methodology.