Every clinical outcome at every future time point.
Predicted with unparalleled precision.
These twins forecast clinical outcomes at every future time point.
Predicted with unparalleled precision.
Digital twins are AI-generated forecasts of an individual trial participant's clinical outcomes. By forecasting clinical outcomes at every future time point with unparalleled precision, they power more rigorous clinical analysis.
Digital Twin Generators (DTGs) are trained on extensive patient-level historical data to forecast individual disease progression under control or standard of care.
In addition to our validated DTGs, Unlearn enables sponsors to build and deploy custom DTGs using their proprietary data, entirely within their own environments and under their control. Deployment is flexible and scalable, available as a web-based application or a secure, on-premises solution within the sponsor's cloud infrastructure.
Built to meet regulatory-grade compliance standards, including GxP, 21 CFR Part 11, and SOC 2 Type 2, Unlearn's technology ensures sponsors maintain complete control over their systems, security, and data integrity.
We encourage you to request our specification sheets to gain a comprehensive understanding of our models, including their capabilities and underlying data.
Disease-specific ML models trained on extensive historical clinical data generate digital twins for each trial participant using only their baseline data.
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Every clinical outcome at every future time point.
Predicted with unparalleled precision.
These twins forecast clinical outcomes at every future time point.
Predicted with unparalleled precision.
Unlearn's methods have been recognized and supported by both U.S. and European regulators.
PROCOVA 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.