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Statistical services

Our statistical services support every stage of the clinical research lifecycle

Robust, insightful, and fit-for-purpose statistical support for clinical research

At Redenlab, we provide high-quality statistical services tailored for clinical trials, digital biomarker studies, and translational research. From early protocol design to regulatory submission and publication, our team ensures your data are analysed with rigor, clarity, and strategic insight.

Focused woman analyzing financial reports in a modern office setting with charts and graphs.

What we offer

Our statistical services support every stage of the clinical research lifecycle

Study design & protocol consultation

Expert input on trial architecture, endpoint selection, and design strategies (e.g., parallel, crossover, adaptive, and platform trials) to align with regulatory and scientific goals.

Sample size estimation & power analysis

Accurate, scenario-based calculations to ensure sufficient statistical power and resource efficiency.

Statistical Analysis Plans (SAPs

Development of detailed, ICH-compliant SAPs including pre-specification of primary/secondary analyses, covariate strategies, and handling of missing data.

Data analysis & interpretation

Execution of advanced analyses, including linear mixed-effects models, survival analysis, Bayesian methods, and multivariate techniques, always with transparent, reproducible reporting.

Randomisation & blinding strategies

Implementation of stratified, block, or adaptive randomisation methods to reduce bias and maintain trial integrity.

Regulatory and scientific reporting


Contribution to regulatory submissions, DSURs, CSR statistical sections, and peer-reviewed manuscripts.

Outcome measure evaluation

Guidance on metric selection, reliability, sensitivity to change, and validation strategy, especially for novel speech and cognitive endpoints.

Technical capabilities

We work across a wide range of statistical environments to ensure compatibility with client pipelines, regulatory expectations, and modern analytical demands. We ensure version control, reproducibility, and documentation standards aligned with GCP and 21 CFR Part 11 compliance.

R

— for flexible, reproducible statistical modelling and visualization

SAS

— for regulatory-grade data analysis and submission-ready outputs

SPSS

— for accessible analyses in behavioural and social science contexts

MATLAB

— for advanced signal processing and algorithm development

Python

— for integrated data science workflows, including machine learning and automation

Our lead biostatistician

Our statistical services are led by Professor Geoff Stuart, a senior academic biostatistician with over three decades of experience in human performance, psychophysics, and clinical research. Geoff has published extensively in experimental design, signal detection theory, and quantitative modelling, and provides strategic and analytical leadership across Redenlab’s clinical programs.

Our experience

Redenlab’s statistical services are grounded in real-world delivery. We have provided statistical and methodological support for:

  • Industry-sponsored trials across neurology, rare disease, and neurodegeneration
  • Government- and foundation-funded grant proposals (NHMRC, MRFF, NIH, EU)
  • Regulatory submissions and scientific manuscripts
  • Development and validation of novel digital outcome measures
  • Pre-study sample size modelling and endpoint sensitivity evaluation

For more information

Contact Us

If you are interested in seeing how Redenlab can help your organisation, please fill in the form and we’ll get in contact with you.