A computational lab for your compound.
From mechanism summary to ranked design, before your first patient.
mechanistic-probabilistic hybrid
1,000-10,000 virtual patients per run
Built around the data you already have
Teams often come to us before their Phase 2 protocol is set. A complete dossier is not required. At pre-IND and early development stages, we can work from mechanism summaries, PK/PKPD parameters from preclinical or healthy volunteer studies, and prior study summaries. Our intake reflects the information available, not an idealized package.
- Compound mechanism summary
- Available PK or PKPD parameters
- Prior clinical or preclinical study summaries
- Target population demographics
- Full molecular structure not required
- Formulation data not required
- Patient-level raw data not required
Mechanistic and probabilistic, not a black box.
Each virtual patient represents a parameterized individual sampled from calibrated physiological distributions. Published literature and calibrated proprietary models inform disease-state variation and response distributions. One run produces 1,000 to 10,000 virtual patients across specified dose levels, showing outcome distributions rather than a single estimate.
The mechanistic model makes assumptions documentable, sensitivity parameters adjustable, and outputs explainable in a pre-IND or end-of-Phase-2 regulatory setting.
Ranked designs, not one recommendation
Each engagement produces decision artifacts: a P(success) heatmap by dose and cohort, responder subgroup analysis, a recommended primary design with rationale, secondary scenario comparisons, and methodology documentation. Outputs are formatted to connect with your existing clinical operations stack.
Outputs for your existing stack
No infrastructure changes are needed. QuantHealth deliverables use formats your clinical operations team already works with.
CDISC ADaM / SDTM-compatible output for submission datasets.
Ready for pre-IND briefing documents or end-of-Phase-2 packages.
Importable flat files for your biostatistics team's internal analysis pipeline.
Programmatic access for multiple compounds.
"The dose-response output gave my biostatistics team something they could truly interrogate. We used it to challenge our initial dose selection before the protocol was locked. Without it, that discussion with the clinical team would not have taken place."
See your compound's simulation results.
One compound, one indication, one pilot engagement. Ranked design outputs arrive before your protocol locks.