Clinical Trial & Clinical Study Consulting

Successful clinical trials require meticulous statistical planning and rigorous analytical expertise to meet regulatory standards and scientific objectives.

As a specialized clinical trial consultant, I help you navigate the complexities of trial design, from protocol development to final analysis and reporting.

Whether you’re a pharmaceutical company developing new treatments, a CRO managing multiple studies, or a research institution conducting investigator-initiated trials, my expertise ensures your clinical research meets the highest scientific and regulatory standards.

Comprehensive Clinical Trial Services

Transform your clinical research concepts into robust, regulatory-compliant studies that generate reliable evidence.

My end-to-end clinical trial services help organizations design, analyze, and report clinical studies with confidence and precision.

Study Design & Protocol Development

Create scientifically sound trial protocols that meet regulatory requirements and research objectives.

  • Design randomized controlled trials, crossover studies, and parallel group designs
  • Develop factorial designs and cluster randomized trials for complex research questions
  • Select appropriate randomization methods and blinding strategies
  • Conduct comprehensive sample size calculations with power analysis
  • Design adaptive trial frameworks that allow for protocol modifications
  • Create detailed statistical analysis plans aligned with regulatory guidelines

Advanced Trial Methodologies

Implement cutting-edge trial designs that maximize efficiency and scientific value.

  • Bayesian trial designs with adaptive decision-making frameworks
  • Adaptive trial designs including sample size re-estimation and futility stopping
  • Platform trials and master protocols for multiple indication studies
  • Seamless Phase II/III designs to accelerate drug development
  • Biomarker-driven and enrichment trial strategies
  • Complex multi-arm and multi-stage trial architectures

Statistical Analysis & Reporting

Deliver comprehensive analyses that meet regulatory submission standards.

  • Primary and secondary endpoint analyses with appropriate statistical methods
  • Intention-to-treat and per-protocol analysis populations
  • Interim analysis planning and data monitoring committee support
  • Subgroup and sensitivity analyses for robust evidence generation
  • Time-to-event analysis and survival modeling
  • Longitudinal data analysis for repeated measures studies
  • Publication-ready tables, listings, and figures (TLFs)

Regulatory Compliance & Submission Support

Navigate regulatory requirements with confidence and precision.

  • FDA and EMA submission-ready statistical sections
  • Comprehensive responses to regulatory queries and requests
  • Statistical sections for Clinical Study Reports (CSRs)
  • Integrated Summary of Safety and Efficacy (ISS/ISE) preparation
  • Advisory committee meeting support and presentation materials
  • Post-marketing surveillance and real-world evidence studies

Data Management & Quality Assurance

Ensure data integrity and analytical reproducibility throughout the trial lifecycle.

  • Statistical programming and validation using industry-standard practices
  • Database design consultation for optimal data collection
  • Data monitoring and quality control procedures
  • Missing data handling and imputation strategies
  • Statistical data review and database lock procedures
  • Audit trail documentation and regulatory compliance verification

Ongoing Trial Support

Beyond initial design, I provide continuous support throughout your trial.

  • Data monitoring committee (DMC) statistical support
  • Interim analysis conduct and reporting
  • Protocol amendment statistical justification
  • Trial simulation and feasibility assessment
  • Risk-based monitoring statistical guidance
  • Trial optimization and efficiency improvement recommendations
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Why Work With Me For Your Clinical Trial Needs?

Working with a clinical trial specialist provides significant advantages for your research program.

Regulatory Expertise

Navigate complex FDA and international regulatory requirements with confidence and precision.

Cost Optimization

Maximize trial efficiency through optimal design choices and sample size planning.

Scientific Rigor

Apply gold-standard statistical methods that ensure robust and defensible results.

Accelerated Timelines

Streamline your development program with efficient trial designs and analysis strategies.

The Clinical Trial Process

My clinical trial consulting process ensures systematic and thorough support for your research needs.

Discovery & Planning Phase

We begin with a comprehensive consultation to understand your research objectives, therapeutic area, regulatory pathway, and timeline requirements.

Protocol Development & Design

Together, we develop the complete statistical framework, including study design, sample size justification, randomization strategy, and detailed statistical analysis plan. All deliverables are provided in a formal proposal with clear timelines and costs.

Analysis & Implementation

I execute the statistical analysis according to the pre-specified plan, handling complex issues like missing data, multiplicity adjustments, and regulatory compliance requirements.

Reporting & Submission

I deliver comprehensive reports including regulatory-ready statistical sections, clinical study reports, and publication-ready manuscripts with all necessary documentation for audit and submission.

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 help with clinical trial design and analysis? From protocol development to regulatory submission, I offer specialized expertise in clinical trial statistics. Together, we can ensure your clinical research meets the highest scientific and regulatory standards.

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CTools and Technologies

Statistical Software Excellence

Using industry-standard software including R, SAS, and Python, I ensure your clinical trial analyses meet regulatory requirements and industry best practices.

Regulatory Compliance Systems

I leverage validated programming environments and documentation systems that support FDA 21 CFR Part 11 compliance and international regulatory submissions.

Specialized Clinical Trial Software

Experience with clinical trial simulation software, adaptive design platforms, and specialized packages for complex trial designs and Bayesian analyses.

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.