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.
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. Our team supports:
- 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
We ensure version control, reproducibility, and documentation standards aligned with GCP and 21 CFR Part 11 compliance.
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
Why partner with Redenlab
- Multidisciplinary insight: Statistical expertise integrated with deep knowledge of speech, cognition, and digital phenotyping.
- Clinical trial-ready: Experienced in trials from Phase 1 to 4, across global regulatory environments.
- Tailored and transparent: Bespoke analytical plans aligned to your study design and outcome goals, always pre-registered, validated, and reproducible.
