Biostatistical Services —
Powered by the Sigma Platform
Engage Sigma BioAnalytics as a standalone consulting partner, or combine expert statistical support with our integrated data cleaning, trial design, and clinical intelligence platform.
Software First. Experts When Needed.
Sigma combines a production-grade analytics platform with hands-on biostatistical expertise — allowing teams to scale from self-service analysis to full-service support without changing tools.
Platform-Only
Use Sigma’s data cleaning, sample size, and CTI tools independently through a monthly subscription.
Hybrid Engagement
Combine Sigma tools with targeted statistical support for design, sensitivity analyses, or regulatory justification.
Full-Service Support
End-to-end statistical leadership delivered by senior biostatisticians, fully integrated with the Sigma platform.
Expert Support Across the Trial Lifecycle
Engage Sigma as software-only, hybrid support, or full-service statistical leadership — depending on where your programme needs depth.
Study Design & Simulation
- Bayesian adaptive designs
- Dose-escalation & dose-finding simulations
- Power & sample size justification
- Interim analysis planning & decision rules
- Protocol & SAP development
PK/PD & Bioequivalence
- Non-compartmental PK analysis
- Population & mechanistic PK/PD modelling
- Dose proportionality & exposure–response
- Bioequivalence (2×2, replicate, scaled designs)
- Simulation-based BE decisions
Real-World Evidence & HTA
- Propensity score methods & causal inference
- Time-to-event & survival modelling
- Treatment-effect estimation
- HTA-aligned economic outputs
- Reproducible RWE pipelines
Regulatory Support
- FDA, EMA & MHRA submissions
- Sample size justification & methodology defence
- Interim analysis documentation
- Scientific advice briefing packages
- Responses to regulatory questions
Statistical Programming & Reporting
- SAS, R & Python programming
- TLFs (tables, listings, figures)
- Automated analysis pipelines
- Reproducible PDF / Word / HTML outputs
- GxP-ready workflows
Academic & PhD Collaboration
- Study design & protocol support
- Power calculations for theses
- Advanced modelling & survival analysis
- Grant & publication support
Not Sure Where to Start?
Use the Sigma platform independently, or speak with our team to design a service engagement that fits your programme.