Regulatory Statistical Guides
Practical, regulator-aligned statistical guidance for clinical trials, bioequivalence, PK/PD, and real-world evidence — written by practicing biostatisticians, not marketing teams.
Designed for Regulated Decision-Making
These guides translate regulatory expectations into concrete statistical decisions — covering study design, analysis choices, assumptions, and documentation. They are intended to support planning and justification, not replace regulatory advice.
FDA Statistical Guidance
Statistical considerations aligned with FDA expectations across clinical trials, bioequivalence, and real-world evidence.
- Sample size justification & power assumptions
- Interim analysis & multiplicity control
- Bioequivalence decision rules
- Use of historical & external controls
EMA Statistical Guidance
EMA- and CHMP-aligned statistical guidance for confirmatory and exploratory clinical development.
- Equivalence & non-inferiority design
- Missing data handling strategies
- Sensitivity & estimand frameworks
- Bioequivalence & PK/PD expectations
MHRA & UK Guidance
UK-specific statistical considerations aligned with MHRA expectations and NICE-related evidence planning.
- Early-phase design considerations
- Adaptive & Bayesian methods
- Use of RWE in UK submissions
- Scientific advice preparation
HTA & Real-World Evidence
Guidance for HTA submissions and RWE studies, focused on transparency, bias control, and reproducibility.
- Causal inference & confounding control
- Propensity score methods
- Survival & comparative effectiveness
- HTA-ready reporting structures
Advanced & Emerging Topics
Forward-looking guidance on modern statistical methods increasingly discussed in regulatory contexts.
- Bayesian dynamic borrowing
- Post-hoc & subgroup analysis
- Adaptive & platform trials
- External control arms
Important Disclaimer
These guides reflect current statistical best practices and published regulatory guidance. They do not constitute legal or regulatory advice and should be interpreted in the context of specific programmes and discussions with regulators.
Need Programme-Specific Regulatory Support?
Sigma’s senior biostatisticians can support scientific advice, protocol justification, and regulatory submissions — integrated directly with the Sigma platform.