Newsletter

Real-World Evidence (RWE) Workshops

Generate robust evidence from real-world data to support decisions and approvals.

Hands-on workshop that equips your teams to design, analyse, and defend regulatory-grade RWE studies using EHR, claims, registry, and other non-experimental data.

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Workshop Specialities

Observational Study Design & Protocol

Design rigorous RWE studies that meet regulatory standards

  • Select and justify real-world data sources

  • Write RWE protocols and SAPs for FDA and EMA

  • Define estimands and target trial elements

  • Meet ENCePP and FDA RWE framework standards

  • Ready-to-use templates from approved studies

Confounding & Selection Bias Control

Master advanced methods to isolate true treatment effects

  • High-dimensional propensity scores and disease risk scores

  • Handle time-varying confounding with marginal structural models

  • Achieve and document covariate balance

  • Doubly robust and targeted learning methods

  • Immediate code in R and SAS

EHR & Claims Data Handling

Transform messy real-world data into analysis-ready cohorts

  • Clean and harmonise raw EHR and claims databases

  • Map data to OMOP CDM and build validated cohorts

  • Manage missing values, coding changes, and unstructured text

  • Create reusable ETL pipelines

  • Work with real datasets during training

Advanced Adjustment & Hybrid Evidence

Bridge RCT and RWE to strengthen your evidence base

  • Combine RWE with RCT data (anchoring, transportability)

  • Construct external control arms for single-arm trials

  • Propensity score calibration and overlap weighting

  • Methods from recent FDA-approved RWE submissions

  • Direct application to ongoing programs

Regulatory & HTA Submission

Navigate regulatory pathways with confidence and clarity

  • Prepare RWE packages for FDA meetings and HTA bodies

  • Anticipate and address common reviewer questions

  • Structure transparent submission dossiers

  • Case studies of successful label expansions using RWE

  • Guidance that shortens review timelines

Reproducibility & Transparency

Build trust through open, reproducible research practices

  • End-to-end reproducible RWE workflow

  • Pre-registration and public code sharing standards

  • Automated TLFs and submission-ready reporting

  • Version control and environment best practices

  • Return ready to lead your next RWE study

Bring practical, regulator-focused training directly to your team. Through hands-on workshops I deliver modern biostatistics, causal inference, and industry-standard tools, transforming complex data into clear, submission-ready insights that accelerate approvals and strengthen your pipeline.

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Flexible Delivery Options

Intensive Multi-Day Workshops

Typically 2–5 day intensive programs. Fully flexible to match your timeline. Featuring hands-on projects and real-world case studies. Certificate of completion included.

Custom In-House Training

Fully tailored programs at your facility or virtual. Aligned with your tools, processes, and therapeutic areas.

Modular Course Series

Monthly or quarterly workshops for continuous skill development from beginner to advanced levels.

On-Demand Support

Post-training consultation for specific project challenges and expert review of analyses.

Organizations We Train

Pharmaceutical & Biotech

Drug developers, medical affairs, regulatory departments, CROs

Academic Research

Universities, hospitals, government research labs

Public Health

Government agencies, parapublic institutions

Woman working with computer in the office of a science laboratory

Medical Device & MedTech

R&D, clinical affairs, post-market surveillance

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Real Applications

12-Hour RWE Intensive for Pharma Company

Delivered a library of training material that is re-used to train and onboard new analysts.

Quarterly Causal Inference Series for Biotech

Monthly office-hours to tackle any challenges faced by client’s teams through Q&A and open discussions about potential solutions and foreseeable difficulties.

Regulatory Biostatistics Onboarding for CRO

Custom small group training to review and enhance statistical analyses of complex biotechnology experiments. Developed re-usable templates tailored to client’s needs for future statistical analyses.

Expert Consultant & Educator

University Teaching Experience

Lecturer at HEC Montreal and ETS Montreal with proven methods for making complex concepts accessible.

Real-World Consulting

Daily work with pharma and biotech organizations ensures training reflects current industry practices.

Thought Leader

Audiences of thousands follow me online for deep and incisive thought-leadership in biostatistics

Customized Content

Tailored to your therapeutic areas, software, regulatory needs, and team levels.

Ongoing Support

Follow-up assistance to ensure successful application of new skills.

Client Feedback

"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
"Our collaborations have resulted in real business impact."
Victor Kang
Lead Scientist @ Spotta, a biotechnology firm
"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-Ratnasingham
Scientists, Arda Therapeutics
"His technical expertise and statistical knowledge is exceptional."
Dr. Robert Whitley
Professor, McGill University