Advanced Clinical Trial Design Solutions

Modern clinical research demands innovative approaches that go beyond traditional randomized controlled trials.

As a specialized clinical trial design consultant, I help pharmaceutical companies, biotech firms, and research institutions implement cutting-edge trial methodologies that accelerate drug development and improve patient outcomes.

Whether you’re developing complex oncology treatments or conducting multi-indication studies, my expertise ensures your clinical trials are statistically sound, operationally efficient, and regulatory compliant.

Comprehensive Clinical Trial Design Services

Transform your clinical development strategy with innovative trial designs that maximize efficiency and minimize risk.

My specialized services help organizations implement advanced trial methodologies that adapt to modern research needs and regulatory requirements.

Study Design & Strategic Planning

Develop sophisticated trial architectures that optimize resource allocation and accelerate development timelines.

  • Design adaptive trials with interim analyses and modification protocols
  • Create master protocol frameworks for multi-arm and multi-stage studies
  • Develop platform trial infrastructures for continuous patient enrollment
  • Plan seamless Phase II/III transitions with integrated statistical approaches
  • Conduct comprehensive feasibility assessments for innovative designs
  • Create regulatory submission packages that clearly communicate design rationale

Specialized Trial Methodologies

Implement cutting-edge trial designs tailored to your therapeutic area and research objectives.

  • Oncology: Comprehensive umbrella and basket trial designs for precision medicine
  • Rare Diseases: Advanced N-of-1 and single patient trial methodologies
  • Neurology: Specialized adaptive designs for progressive disease studies
  • Cardiovascular: Platform trial approaches for multi-indication development
  • Immunology: Innovative biomarker-driven adaptive trial strategies
  • Pediatrics: Ethical and efficient trial designs for vulnerable populations

Results Analysis & Regulatory Communication

Present your innovative trial results with statistical rigor and regulatory clarity.

  • Generate comprehensive statistical analysis plans for complex designs
  • Develop interim analysis protocols with appropriate stopping rules
  • Create detailed methodology sections for regulatory submissions
  • Document design modifications and their statistical implications
  • Prepare robust responses to regulatory agency questions
  • Design clear visualizations that communicate complex trial architectures
  • Craft executive summaries highlighting design advantages and outcomes

Advanced Statistical Implementation

Apply sophisticated statistical methods specific to innovative trial designs.

  • Bayesian adaptive randomization and dose-finding algorithms
  • Group sequential methods with flexible monitoring boundaries
  • Multi-arm multi-stage (MAMS) trial analysis frameworks
  • Seamless design transition protocols and data integration
  • Platform trial statistical coordination across multiple studies
  • Response-adaptive randomization with covariate adjustment
  • Hierarchical modeling for umbrella and basket trial analysis

Decentralized & Hybrid Trial Operations

Navigate the complexities of modern trial conduct with remote and virtual components.

  • Design hybrid protocols balancing site visits with remote monitoring
  • Implement virtual trial technologies with appropriate statistical considerations
  • Address regulatory requirements for decentralized trial conduct
  • Develop data quality assurance protocols for remote data collection
  • Create patient-centric trial designs that improve retention and compliance
  • Establish statistical methods for handling missing data in virtual settings
  • Design adaptive protocols that accommodate operational flexibility

Ongoing Consultation & Support

Beyond initial design, I provide comprehensive project guidance.

  • Real-time consultation during trial conduct and adaptation decisions
  • Expert review of interim analysis results and modification recommendations
  • Training sessions on innovative trial methodology implementation
  • Strategic guidance for future trial portfolio development
  • Regulatory meeting preparation and statistical section support
  • Post-trial analysis and methodology publication assistance
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Why Work With Me For Your Clinical Trial Design Needs?

Working with a specialized consultant provides significant advantages for your clinical development program.

Accelerated Development

Reduce timelines through efficient adaptive designs and seamless trial transitions.

Risk Mitigation

Navigate regulatory complexities with confidence through proven innovative methodologies.

Cost Optimization

Maximize resource efficiency with adaptive sample sizes and platform trial approaches that share infrastructure costs.

Regulatory Confidence

Ensure your innovative designs meet FDA and EMA expectations through rigorous statistical planning and clear documentation.

The Clinical Trial Design Process

My consulting process ensures your innovative trial designs are both scientifically sound and operationally feasible.

Discovery & Feasibility Phase

We begin with a comprehensive assessment of your development goals, therapeutic area requirements, and regulatory landscape to identify optimal trial design opportunities.

Protocol Development & Planning

Together, we create detailed trial protocols including statistical analysis plans, operational procedures, and regulatory submission strategies. This phase includes formal design documentation and feasibility assessments.

Implementation & Monitoring

I provide ongoing support during trial conduct, including interim analysis oversight, adaptation decisions, and real-time statistical guidance for complex operational challenges.

Analysis & Reporting

I deliver comprehensive statistical analyses, regulatory-ready reports, and publication-quality documentation that clearly communicates your innovative methodology and results.

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

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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 innovative clinical trial designs? From adaptive protocols to platform trials, I offer specialized expertise in modern clinical research methodologies. Together, we can optimize your development strategy and accelerate your path to regulatory approval.

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Tools and Technologies

Statistical Software & Programming

Utilizing advanced statistical platforms including R, SAS, and Python with specialized packages for adaptive designs, Bayesian analysis, and clinical trial simulation.

Clinical Trial Platforms

Experience with leading clinical trial management systems, electronic data capture platforms, and innovative technologies supporting decentralized trial conduct.

Regulatory Frameworks

Deep familiarity with FDA and EMA guidance documents for innovative trial designs, including adaptive trials, master protocols, and decentralized study conduct.

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.