Statistical
Insight.
Therapeutic
Value.

Building robust evidence for confident clinical and market access decisions.

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Statistical analytics in clinical research
For confident decisions.

We provide advanced statistical analyses and methodological expertise for late phase clinical development, HTA and market access.

As evidence requirements continue to evolve, clinical development, regulatory submissions and market access increasingly depend on robust statistical evidence and transparent analytical methods.

Numerus supports pharmaceutical, biotechnology and medical technology organisations across all countries in Europe and the US.

From study design and statistical planning to indirect treatment comparisons, real-world evidence and analyses for reimbursement, we help organisations reduce uncertainty and strengthen confidence for critical decisions.

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Our experience


20+ years
Statistical analysis in clinical research

Phase III–IV
Clinical development

Regulatory & HTA
Evidence generation

Complex evidence
Rigorously analysed

Experience & Impact ➝

Typical decision challenges

Understanding the challenges before making critical decisions.

Clinical study statistics

Supporting robust clinical

development from study

design to submission

How can clinical uncertainty feed into statistical trial design?

How can real-world data supplement controlled clinical trials for regulatory and market access submissions?

Which analyses remain scientifically defensible and acceptable to the regulator?

For successful European HTA, how should the phase III studies be designed?

Market access & HEOR

Generating robust evidence for

pricing, reimbursement and

access decision

Which uncertainties become decision-critical?

How can evidence, generated in one setting, support decisions in another?

When is evidence considered sufficient?

How should clinical and economic evidence work together?

Our approach

From uncertainty to confident decisions.

Robust evidence begins long before submission.

Our approach combines statistical expertise, regulatory experience, and analytical rigour to strengthen evidence throughout late-phase clinical development, HTA and market access.

Navigating customer challenges in clinical research, regulatory submissions, HTA and market access before identifying the right answers.
Key Challenges

Understanding the questions before searching for answers.

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Applying statistical methods to clinical research and real-world evidence across clinical development, HTA and market access.
In Practice

Applying robust analytics to real-world evidence challenges.

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Evidence Decoded

Understanding how regulators and HTA reviewers evaluate evidence.

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Illustrating the analysis of clinical data to generate reliable evidence and support healthcare decision-making.
Experience & Impact

Evidence from real-world projects and measurable outcomes.

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Visualising complex data structures and statistical methods to support transparent, robust evidence analysis.
Robust Analytics

Building confidence through transparent statistical logic.

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Representing interconnected statistical concepts and scientific insights in clinical evidence generation and HTA methodology.
Insights

Perspectives on evidence generation, JCA and statistical methodology.

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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.


See selected case studies ➝

Implementation of ML-NMR for Rate Outcomes

Lessons from a Recent EU HTA Submission

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Case Snapshot ➝

From feasibility and power assessment to study protocol

Case Snapshot ➝

Hyper complex NMA successfully executed

Latest insights

Multiplicity in EU Joint Clinical Assessment

Preparing evidence for evolving assessment requirements.

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Utilising real-world data for EU HTA

Identifying critical evidence before it becomes a barrier.

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Polynomial-Based MAIC

Developing state of the art statistical methodology for successful reimbursement decisions.

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The people behind the work

We bring the thinking, rigour and care behind your projects.

Why clients trust us ➝

Your next evidence challenge

Have an evidence question?


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