In practice:
real-world
applications
Statistical analysis
Across clinical development, HTA and market access
In clinical development, HTA and market access, evidence often needs to address complex populations, comparators, endpoints and data sources across different assessment contexts.
We apply rigorous statistical methods to generate, analyse and interpret clinical and real-world evidence throughout the evidence lifecycle.
Real evidence.
Real decisions.
Late-phase evidence generation rarely follows a simple path. Evidence may need to answer different questions across studies, data sources, markets and assessment contexts.
The challenge is not simply to produce more analyses.
It is to understand which analyses are relevant, defensible and decision-critical.
Common challenges.
Include:
- Limited head-to-head evidence
- Differences between study populations and treatment settings
- Fragmented IPD, aggregate and real-world data
- Multiple PICO requirements across markets
- Complex endpoints
- Conflicting estimands
- Compressed timelines for evidence generation and assessment
What we do
We translate complex evidence requirements into rigorous statistical analyses tailored to the relevant study, evidence base and assessment context.
HTA evidence generation
Comparative effectiveness analyses for HTA submissions, including direct and indirect treatment comparisons, network meta-analysis and population-adjusted methods such as MAIC, STC and ML-NMR.
Statistical modelling
Survival analysis, extrapolation and advanced statistical models for long-term outcomes and cost-effectiveness analyses.
Market access & pricing analytics
Statistical analyses supporting pricing and reimbursement, including comparative effectiveness, subgroup analyses, survival modeling and analyses of long-term treatment outcomes.
Real-world evidence
Statistical design and analysis of registries, observational studies and electronic health records to generate clinically relevant real-world evidence.
Clinical study design & SAP
Feasibility and power assessments, study design, protocol development and Statistical Analysis Plans incorporating clinical, regulatory and HTA evidence requirements throughout clinical development.
Value dossier support
Reproducible statistical analyses, dynamic visualisation of results, AI-driven documentation for global and national HTA and value dossiers.
Where we apply it
➝ JCA
➝ JSC
➝ AMNOG
PICO-specific feasibility, comparative analyses and statistical evidence generation across multi-market assessments.
➝ HAS
➝ G-BA
➝ IQWiG
Added-benefit assessment, comparator requirements and relevant subpopulation analyses within the German framework.
➝ NICE
➝ SFOPH
➝ International markets
HTA, reimbursement and cost-effectiveness analyses adapted to local populations, comparators and endpoints.
SIGMA
A statistical infrastructure for global market access
Managing complex statistical workflows.
Large evidence programmes can require extensive analyses across studies, PICOs, markets and data sources.
SIGMA supports the structured management, automation and summarisation of complex statistical workflows, helping teams maintain consistency, traceability and transparency at scale.
Our work in practice
Selected examples of complex statistical questions and how we addressed them across clinical development, HTA and market access.
Over 1,000 projects delivered.
Numerus invented a new MAIC methodology
Hyper complex NMA successfully executed
The value in practice
Our statistical analyses help teams generate evidence that is transparent, reproducible and appropriate for the clinical and assessment context.
From study design and analysis planning to HTA evidence generation and real-world data, we support the statistical work behind complex evidence programmes.
Your next evidence challenge
Have an evidence question?