Know Before You Enroll.
End-to-end clinical trial simulation. Predict outcomes, identify failure modes, and optimize your protocol — before any patient is touched.
Full Trial Architecture, In Silico
OVIVO's trial simulation infrastructure reconstructs full trial architectures before a single site is opened. Each configuration encodes the complete trial design: cohort demographics and comorbidity distributions calibrated to published baseline tables, treatment arm specifications, primary and secondary endpoints. The simulation runs each patient through the full mechanistic chain — genetics, PK, PD, pathway engagement, disease progression — and produces outcome distributions that can be directly compared against those endpoints.
The platform currently holds 680+ trial configurations across oncology, cardiovascular, metabolic, neurodegenerative, immunology, rare disease, and other therapeutic areas. Confidence intervals propagate through the full simulation chain. The output tells you not just what is predicted, but how confident the prediction is.
What Partners Use It For
From protocol design to competitive positioning, the simulation infrastructure applies across the full lifecycle of a trial program.
Protocol Optimization
Simulate alternative dosing regimens, patient selection criteria, endpoint definitions, and treatment durations before committing to a design. A trial that would have failed due to an inadequate dose or a misaligned endpoint can be corrected before the first site opens.
Futility Prediction
If the mechanistic model predicts the effect size is too small to meet the primary endpoint at planned sample size, that is information worth having before the Phase IIb spend. Not all trials should be stopped — but some should be redesigned.
Patient Enrichment
Define the biological criteria that predict response. Sharpen enrollment toward the patients most likely to benefit. Increase signal while reducing the required N — without the cost of a failed enrichment strategy discovered mid-trial.
Subgroup Analysis
Simulate differential response across genetically defined subpopulations, comorbidity strata, and demographic groups. Know which patient segments drive the effect — and which are at elevated risk — before the trial commits to its stratification strategy.
Competitive Intelligence
Reconstruct competitor trial architectures and simulate what their pipeline compounds are likely to produce — before the readout. Understand the competitive landscape mechanistically, not just analytically.
Rare & Orphan Disease
Individual-level simulation is particularly well-suited to rare disease development where clinical populations are small and natural history data is sparse. The platform's n=1 capability generates meaningful signal where conventional trial design cannot.
Simulation only matters if it's accurate. 95% directional accuracy across 680+ validated trials — correctly predicting whether a trial will be positive or negative. Not a model trained on trial outcomes. A mechanistic engine that models the biology directly.
Trials Reconstructed
The published trials the platform has reconstructed in silico, validated against reported outcomes across oncology, cardiovascular, metabolic, neurodegenerative, immunology, rare disease, and more.
Co-Development
For Pharma, Biotech, and CRO partners looking to apply trial simulation to protocol design, pipeline de-risking, patient enrichment, or competitive analysis.
develop@ovivolabs.comInvestments
An independently verifiable prediction record across drug development's most expensive failure points. Growing validation library. Clear trajectory.
invest@ovivolabs.comMedia & Research
Press inquiries, academic collaboration, and general research questions about the platform's methodology and validation record.
media@ovivolabs.com