Targeted Machine Learning

Causal AI for Decisions that Matter

Generate trustworthy, regulator-ready evidence from clinical trials and real-world data using the industry's most advanced causal machine learning platform.

Targeted Learning with TML Pro brings together machine learning, rigorous statistical theory and targeted maximum likelihood estimation (TMLE)-based causal inference so you can act on results with confidence.

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The Latest

Our collaboration with the FDA and UC Berkeley on “A CV-TMLE Global Test Approach to Multiple-Component Endpoints in Rare Disease Clinical Trials” was awarded Best Poster at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop.

The Problem

Inferior data analysis drives costly mistakes.

General-purpose AI can generate predictions but it cannot tell you how confident you should be in acting on them. Traditional statistical methods provide inference but often break down when faced with modern, complex data.

As a result, pharmaceutical and healthcare organizations struggle to generate reliable evidence:

  • RCTs can suffer from informative drop-out and intercurrent events
  • RCTs may be under-powered for primary or secondary analyses
  • Treatments are not randomized in real-world data
  • Outcomes are missing or censored
  • Traditional methods lack flexibility
  • Black-box AI lacks interpretability

The result: delayed decisions, failed trials, wasted capital, and avoidable risk.

TML Pro analysis workflow TML Pro results output TML Pro dashboard

The Solution

Built by the inventors. Trusted by the standard-setters. Proven in practice.

TML Pro for PHARMA is the industry standard for causal machine learning, delivering trustworthy evidence for real decisions, not just predictions.

It delivers:

  • Unbiased causal estimates
  • Valid confidence intervals and p-values
  • Reproducible, interpretable, regulator-ready results

At its core, TML Pro pairs Targeted Maximum Likelihood Estimation (TMLE) with Super Learning, guiding users through the full Targeted Learning Causal Roadmap from study design to final reporting.

TML Pro analysis workflow TML Pro results output TML Pro dashboard

The Product

TML Pro Pharma

Enterprise causal machine learning software for pharmaceutical companies, regulators, and healthcare researchers. Generate reliable, regulator-ready evidence from complex clinical trials and real-world data—without sacrificing rigor or usability.

TML Pro Pharma supports the full analytic lifecycle, from study design to final reporting:

  • Study design and Statistical Analysis Plan (SAP) development
  • Data verification and preprocessing
  • Causal effect estimation using TMLE + Super Learning
  • Diagnostics, sensitivity analyses, and robustness checks
  • Automated reporting and visualization

Interested?

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Technical Resources

Learn. Explore. Go Deeper.

We provide a growing library of resources for decision-makers, analysts, and researchers looking to understand and apply causal machine learning in practice.

  • Documentation & Technical Guides

    Detailed software documentation, vignettes, and examples for TML Pro users.

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  • Training Programs

    Online and on-site courses covering Targeted Learning, TMLE, and Super Learning for applied teams.

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  • Publications & Research

    Peer-reviewed papers, white papers, and collaborative research with academic and regulatory partners.

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  • Reddit Community Forum

    Engage with us and our community as we discuss foundational concepts and real-world applications.

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About Targeted ML Solutions

Causal AI, built by the inventors.

Targeted ML Solutions is a healthcare analytics company advancing the science and practice of causal machine learning. We build production-grade software that enables organizations to generate reliable, regulator-ready evidence from complex clinical trials and real-world data.

The company was founded by leaders in causal inference and machine learning with decades of academic and applied experience.

Together, they lead a team committed to transforming how high-stakes decisions are made from data.

  • Mark van der Laan, PhD

    Mark van der Laan, PhD

    Co-Founder & CEO

    Professor of Biostatistics at UC Berkeley and inventor of Targeted Learning and Targeted Maximum Likelihood Estimation (TMLE). A globally recognized leader in causal inference and machine learning, Mark's work underpins much of modern causal AI in healthcare and regulatory science.

  • Susan Gruber, PhD, MPH, MS

    Susan Gruber, PhD, MPH, MS

    Co-Founder & President

    Former Harvard Medical School faculty and Reagan-Udall Foundation leader, Susan is a pioneer in applied TMLE and real-world evidence. Her work bridges advanced methodology with practical decision-making for regulators, industry, and public health.

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Ready to Make Confident Decisions from Complex Data?

Whether you're evaluating a clinical program, building internal analytics capabilities, or exploring causal AI for real-world evidence, we'd love to talk.

  • Request a demo of TML Pro
  • Discuss training or consulting
  • Ask a technical or partnership question

Enterprise deployments available. On-premise options supported.

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