PROCOVA™ Handbook for the Target Trial Statistician

The European Medicines Agency recently released a draft qualification opinion on our 3-step PROCOVA™ procedure for Phase 2 or 3 TwinRCTs™. To help target trial statisticians understand how to implement PROCOVA, we’ve created this handbook which provides a brief overview of the methodology and instructions covering 1) how to validate the prognostic score generated by a prognostic model for use in a particular planned trial, 2) how to estimate the sample size and plan the Target Trial using PROCOVA for the primary analysis, 3) how to estimate the treatment effect using a linear model while adjusting for the prognostic score and assess a null hypothesis by computing a two-sided p-value based on a t-distribution.

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Unlearn Closes $50 Million Series B Funding to Advance the Use of Its Machine Learning-Powered TwinRCTs™ in Clinical Trials


Unlearn Signs Multi-Year Collaboration with Merck KGaA, Darmstadt, Germany to Accelerate Immunology Trials using Twintelligent RCTs™


Success is never a straight line—reflecting on our EMA draft qualification opinion

On March 22, 2022, we reached an historic milestone with the European Medicines Agency’s release of a draft qualification opinion on our 3-step PROCOVA™ procedure.
Collaborators will leverage AI-generated Digital Twins to enable smaller, more efficient pivotal clinical trials.
Led by Insight Partners, financing builds on the company’s momentum in working with leading biopharmaceutical companies to improve clinical trial efficiency.