ClinicalSim
ClinicalSimby Bajpai Labs
Services

Four simulation pipelines. Built for phase transition decisions.

Every engagement returns quantified outcome probabilities plus the technical documentation your clinical development and regulatory teams need for go/no-go decisions.

Service 01

Toxicity & DILI Prediction

Quantifying hepatotoxicity and safety failure risk before Phase II enrollment on a lead small molecule.

Timeline
3 weeks
Starting price
Engagements typically $125K–$350K per program
Process
  1. 01Integrate Phase I PK, preclinical tox, and compound liability data
  2. 02Build PBPK model for hepatic exposure across virtual patient cohort
  3. 03Run mechanistic DILI simulation with co-medication and genotype stratification
  4. 04Deliver ranked dose scenarios with failure probability and backup compound comparison
Deliverable
Go/no-go recommendation · DILI probability by regimen · board decision deck
Service 02

PK/PD Dose Optimization

Identifying minimum efficacious dose and eliminating redundant arms in oncology or specialty Phase II designs.

Timeline
3–4 weeks
Starting price
Engagements typically $200K–$400K per program
Process
  1. 01Population PK model from Phase I rich/sparse sampling data
  2. 02Exposure-response and tumor growth inhibition calibration
  3. 03Drug-drug interaction simulation for combination protocols
  4. 04Virtual trial simulation across dose arms with toxicity tradeoffs
Deliverable
Recommended dose · eliminated arm analysis · FDA briefing addendum
Service 03

Trial Success Probability Modeling

Quantifying Phase III success probability for biologics with population mix different from Phase II.

Timeline
4–5 weeks
Starting price
Engagements typically $300K–$500K per program
Process
  1. 01Bayesian meta-analysis of published Phase III benchmarks
  2. 02Individual patient data modeling from Phase II with dropout imputation
  3. 03Monte Carlo virtual trial (10,000 iterations) under planned protocol
  4. 04Sample size optimization and endpoint selection sensitivity analysis
Deliverable
Success probability · optimized sample size · endpoint failure mode report
Service 04

Adaptive Design Simulation

Optimizing interim looks, futility boundaries, and enrichment strategies before protocol lock.

Timeline
3–4 weeks
Starting price
Engagements typically $250K–$450K per program
Process
  1. 01Calibrate outcome models from Phase I/II accumulating data
  2. 02Simulate interim analysis performance under multiple boundary rules
  3. 03Model enrichment strategies by biomarker or prior exposure status
  4. 04Deliver protocol amendment recommendations with operating characteristics
Deliverable
Interim boundary specification · enrollment scenario timelines · DSMB briefing support
Methodology

The science behind the simulation.

We compose published pharmacometric methods with proprietary calibration trained on observed clinical outcomes from closed engagements.

Population PK/PD

NONMEM and Monolix models with covariate search and bootstrap validation.

PBPK simulation

Organ-level exposure modeling for liver, tumor, and cardiac tissue distribution.

Mechanistic tox

DILIrank, reactive metabolite, and BSEP inhibition integrated with exposure thresholds.

Virtual trials

Monte Carlo engines projecting ORR, PFS, safety signals, and primary endpoint success.

Custom & Enterprise Projects

Multi-indication simulation, integration with clinical data warehouses, real-time model updates as trial data accumulates, and bespoke calibration on proprietary outcome datasets.

  • Multi-indication trial simulation
  • CDISC data integration
  • Real-time interim model updates
  • Custom outcome calibration
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