Biostatistics
Academic-Grade Biostatistics
Statistical depth from study design through final analysis.
Biostatistics sits at the core of ACRO — turning clinical questions into defensible statistical answers. From sample size calculation through final analysis, we deliver statistical work that meets the standards of regulatory submission and payer evaluation.
Academic methodology and industry execution in a single deliverable — pre-specified, transparent, and documented as if every analysis will be audited.
Related reading
Why it matters
Statistical quality determines whether a trial's data tells a clear story or invites endless reviewer questions. Pre-specification, estimand framing, sensitivity analysis, and transparent handling of intercurrent events are no longer optional — they're the standard. Sponsors who skip these steps pay for it in regulatory exchanges and reimbursement scrutiny later.
What we offer
Trial-level statistics
- Statistical Analysis Plan (SAP) development
- Sample size and power calculation
- Estimand framework definition (ICH E9(R1))
- Randomization design
Analysis and reporting
- Statistical analysis execution (primarily R)
- Tables, Listings, Figures (TLF) generation
- Interim analysis and DMC statistical support
- Statistical report writing
Specialized methods
- SAP-driven statistical analyses — survival, mixed-effects, longitudinal, and Bayesian methods
- Adaptive and group-sequential designs
- Meta-analysis — network and pairwise
- Real-world evidence statistical analysis
How we work
Every engagement starts with the research question and the regulatory pathway. We pre-specify analytical approaches in the SAP, document assumptions transparently, and deliver analyses with sensitivity checks built in. The output is statistical work that holds up under scrutiny — regulatory or payer.
Related services
- Protocol Development — protocol scope and design choices flow into the analysis plan
- PK/PD Modeling — pharmacometric and biostatistical work as one
- Data Use & Regulatory Strategy — external control and indirect comparison methods