Trusted by leading sponsors.
Grounded in science.
Proven in trials.
Leading biopharma sponsors use Unlearn’s AI-powered products and solutions to design smarter trials and derive stronger signals from every participant, backed by regulatory alignment and a foundation of rigorous research.
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Regulatory Acceptance
Paving the regulatory path for AI in clinical trials
Unlearn’s methods have been recognized and supported by both U.S. and European regulators.
Our digital twins-based method was officially qualified by the European Medicines Agency for use in Phase 2 and 3 trials with continuous outcomes.
U.S. FDA provided positive feedback on PROCOVA, supporting its use in covariate-adjusted analyses across clinical development.
FDA recommends that sponsors adjust for covariates that are anticipated to be most strongly associated with the outcome of interest…it may be useful to use previous studies to select prognostic covariates or form prognostic indices.
In a trial that uses covariate adjustment, the sample size and power calculations can be based on adjusted or unadjusted methods.
End-to-end AI-Powered Solutions
Driving Impact Across Clinical Development
Explore how our partners are accelerating their clinical development programs with us.
Case Studies
Product
TrialPioneer
Reach confident, evidence-backed trial design decisions earlier — before protocols are finalized.
Faster, more confident trial design decisions
Clearer trade-offs when evaluating endpoints, populations, and sample size
Fewer handoffs between literature review, data analysis, and simulation
Preserved decision context as designs evolve
“Working with Unlearn to mine their extensive, well-curated database through the use of the ALS DTG will enable us to explore smarter designs and make confident and informed decisions as we plan our Phase 1/2 trial. Ultimately, these insights can help us to move faster for people living with ALS who are waiting for new treatment options."
Product
Participant's
digital twins
AI-generated forecasts of individual study patients’ control outcomes provide clearer, earlier signals at every interim timepoint, enabling more confident go/no-go decisions.
Reduce sample sizes
Maintain statistical power with fewer participants
Boost power
Derive stronger signals without adding participants
Earlier go/no-go decisions
Clearer signals at every interim timepoint
Conference Highlights
Unlearn x ProJenX
Development
Summit 2025
Boston, MA
Unlearn x AbbVie
Conference
Vienna, Austria
Why leading sponsors choose unlearn
Explore the Science
Our technology is built on a foundation of rigorous scientific research across therapeutic areas, from neurodegenerative diseases to oncology and obesity. Explore the full library.
Data & Platform Strengths
Experts in Data Sourcing and Operationalizing Unstructured Data
Unlearn has deep expertise in transforming complex clinical data into AI-ready formats. Our technology draws from over 1 million longitudinal clinical study records and spans 20+ indications, including neuroscience, immunology, cardiovascular, and metabolic diseases. This rich data foundation powers scalable, scientifically rigorous disease-specific ML models with exceptional performance.
