Non-Clinical Research & Preclinical Studies Statistical Consulting

Non-clinical research forms the foundation of safe and effective product development across pharmaceuticals, biotechnology, and medical devices.

As a specialized non-clinical research consultant, I provide comprehensive statistical support for preclinical studies, from initial study design through regulatory submissions.

Whether you’re conducting toxicology studies, pharmacokinetics assessments, or preparing for pre-IND meetings, my expertise ensures your non-clinical data meets regulatory standards and supports successful product advancement.

Comprehensive Non-Clinical Research Services

Transform your preclinical data into compelling regulatory evidence.

My statistical consulting services support every aspect of non-clinical research, helping you navigate complex regulatory requirements while maximizing the value of your preclinical studies.

Study Design & Protocol Development

Build robust non-clinical studies that generate reliable, defensible data.

  • Design optimal study protocols for toxicology, pharmacokinetics, and safety pharmacology studies
  • Develop appropriate statistical analysis plans for GLP compliance
  • Calculate sample sizes for in vivo studies considering animal welfare principles
  • Plan dose-ranging studies with proper statistical power
  • Create randomization schemes that minimize bias in preclinical studies
  • Design crossover and parallel group studies for maximum efficiency

Regulatory Statistics & Compliance

Navigate regulatory requirements with confidence and precision.

  • Prepare statistical sections for IND submissions and regulatory dossiers
  • Develop analysis strategies that meet FDA, EMA, and ICH guidelines
  • Create comprehensive statistical reports for pre-IND meeting support
  • Ensure GLP compliance in all statistical documentation
  • Prepare responses to regulatory questions on statistical methodology
  • Support non-clinical endpoint selection and justification

Specialized Study Analysis

Advanced statistical methods for complex non-clinical research questions.

  • Pharmacokinetics and pharmacodynamics modeling (PK/PD)
  • ADME studies with population pharmacokinetic approaches
  • Toxicokinetic analysis and dose-response modeling
  • Safety pharmacology data analysis and interpretation
  • In vitro and in vivo correlation studies
  • Predictive modeling for human dose projection

Data Integration & Meta-Analysis

Synthesize evidence across multiple non-clinical studies.

  • Integrate data from multiple preclinical studies for comprehensive assessment
  • Conduct meta-analyses of toxicology and efficacy data
  • Perform cross-study comparisons and trend analysis
  • Develop integrated safety summaries for regulatory submissions
  • Create pooled analyses for rare adverse events
  • Support weight-of-evidence approaches for risk assessment

Risk Assessment & Safety Evaluation

Quantify risks and support safety decision-making.

  • Conduct quantitative risk assessments using non-clinical data
  • Develop safety margins and therapeutic index calculations
  • Perform benchmark dose modeling for toxicology studies
  • Create probabilistic risk models for human safety prediction
  • Support no-observed-adverse-effect-level (NOAEL) determinations
  • Develop integrated risk-benefit frameworks

Ongoing Support & Training

Comprehensive support throughout your non-clinical development program.

  • Provide statistical consultation for study conduct and interim analyses
  • Offer training on statistical methods in non-clinical research
  • Support data monitoring committee activities
  • Assist with regulatory meeting preparation and follow-up
  • Provide expert witness support for regulatory proceedings
  • Keep you updated on evolving statistical guidelines and best practices
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Why Work With Me For Your Non-Clinical Research Needs?

Working with a non-clinical research statistics expert provides significant advantages for your development program.

Regulatory Expertise

Navigate complex regulatory requirements with confidence and avoid costly delays.

Scientific Rigor

Apply appropriate statistical methods that strengthen your scientific conclusions and regulatory arguments.

Efficient Resource Use

Optimize study designs to minimize animal use while maximizing information content, supporting ethical research practices.

Regulatory Success

Increase your chances of successful regulatory submissions through proper statistical planning and analysis.

The Non-Clinical Research Process

My statistical consulting process is designed for regulatory success and scientific excellence.

Initial Assessment

We discuss your non-clinical development needs, regulatory timeline, and specific statistical challenges. I review your compound profile and development strategy.

Statistical Strategy Development

Together, we create a comprehensive statistical plan covering study designs, analysis methods, and regulatory considerations. This includes formal statistical analysis plans and sample size justifications.

Study Support & Analysis

I provide ongoing statistical support during study conduct, perform sophisticated data analysis using appropriate methods, and handle complex issues like missing data and protocol deviations.

Regulatory Documentation

I deliver comprehensive statistical reports, regulatory-ready summaries, and detailed methodology documentation. For urgent regulatory questions, I provide rapid consultation services.

For urgent questions, my on-demand consultation service offers quick, cost-saving solutions.

Book Express Consultation

Case Studies

I worked on large medical datasets to answer causal questions related to epidemiological determinants of disease through complex exposures. Challenges included selection bias, confounding, and missing data. I successfully developed a strategy that gave researchers confidence in their results.
I’ve worked with R&D scientists who were simultaneously running multiple experiments to answer important questions about their cutting-edge products that would have a direct impact on various stakeholders. My role was to help in designing and analyzing the experiments, balancing the conceptual purity of the Design of Experiments theory (DoE) with pragmatic concerns relating to costs and timeline. Most of this work is sealed behind a Non-Disclosure Agreement (NDA) which prevents me from elaborating more.

Don’t Just Take My Word For It…

The positive experiences of my happy collaborators showcased through their glowing testimonials, serve as powerful proof of trustworthiness and the impact of the results I deliver. These testimonials offer real-life examples of how I’ve helped research projects succeed. Here are some of their thoughts:

5/5

"He has a deep understanding of statistics, yet is able to skillfully explain complex concepts to people with little-to-no background in statistics both in French and English."

Elsa Brunet-Ratnasginham

Post-doc, UCSF

5/5

"I had never before worked with a biostatistician who speaks the same language as me! [...] Personally, our collaboration has allowed me to reconcile with statistics."

Manon Nayrac

Post-doc, CRCHUM

5/5

"I highly recommend Justin and his team for your data processing needs in order to have a more robust statistical model than the tests we are accustomed to conducting as biologists!"

Gérémy Sannier

Ph.D candidate, CRCHUM

5/5

"Thanks to him, statistics appeared to me as solutions rather than obstacles."

Mathieu Dubé

Research Associate, CRCHUM

Read Full Collaborator Testimonials
Justin Belair - Causal Inference Expert

My Statistics and Causal Inference Expertise

As a university-level statistics lecturer with a substantial LinkedIn following, scientists from all over the world come to me for my unique combination of academic excellence and practical experience in statistics and causal inference.

I’ve applied causal inference methods in varied settings in both academia and industry: in biomedical sciences such as nephrology, immunology, neuroscience, virology, occupational therapy, epidemiology, dermatology, psychiatry, and oncology; in natural sciences such as agronomy, ecology, and zoology; and social sciences such as communication, and psychology. The list keeps on growing!

I am currently writing an advanced textbook that I hope will give a young generation of academic and industry researches the tools needed to grapple with the complexities of causal inference, and maybe even develop a passion for the subject!

Need statistical support for your non-clinical research program? From study design to regulatory submissions, I provide the expertise to advance your preclinical development successfully.

Let's Talk

Tools and Technologies

Using industry-standard statistical software including R, SAS, and specialized pharmacokinetic modeling tools, I ensure your non-clinical analyses meet the highest regulatory standards.

I leverage advanced computational methods for complex modeling tasks, including population PK/PD analysis, toxicokinetic modeling, and dose-response analysis using specialized software like Phoenix WinNonlin and NONMEM.

My experience includes all major statistical platforms used in pharmaceutical research: SAS, R, SPSS, Stata, and specialized tools for regulatory submissions and data visualization.

Client Industries Served

My statistical consulting expertise extends beyond specific industries, serving clients in fields ranging from R&D in biotechnology and pharmaceuticals to researchers and Principal Investigators (PI) in academia.