by Bajpai Labs · Clinical simulation
Predict trial outcomes before Phase II begins.
ClinicalSim simulates PK/PD exposure, toxicity risk, and trial success probability so your team commits capital to the right dose and design, not a coin flip.
Simulation pipeline
- PK/PD Model Build01Population PK · PBPK · exposure reconstruction from Phase I data
- Outcome Simulation02Toxicity scoring · exposure-response · virtual trial Monte Carlo
- Decision Package03Dose rankings · success probability · board-ready regulatory brief
- 73–93%
- Prediction accuracy
- $2.4–16M
- Capital preserved per program
- 3–5 wks
- Typical delivery
Phase II failures cost $20M+ and 18 months. Most were predictable.
Phase II and Phase III programs commit massive capital before exposure-response and safety risk are quantified under real patient variability.
A failed Phase II restarts the clock on enrollment, regulatory strategy, and investor milestones. DILI holds average 14 months to resolution.
Half of Phase II programs fail on efficacy or safety. Standard power calculations do not model population mix, co-medications, or mechanism-based tox.
A clinical simulation pipeline that quantifies risk before enrollment begins.
- 01
Upload your clinical data
Provide Phase I PK, preclinical tox, protocol draft, and target population criteria.
- 02
Simulation engine runs
Population PK/PD, PBPK exposure, toxicity models, and virtual trial Monte Carlo.
- 03
Decision package delivered
Ranked dose scenarios, success probability, and FDA-ready exposure-response brief.
Built for phase transitions, not dashboards.
Every architectural choice in ClinicalSim serves one goal: give your team quantified go/no-go decisions before capital is committed.
Most teams commit Phase II capital on preclinical assumptions alone. ClinicalSim quantifies hepatotoxicity risk, dose-response, and trial success probability before the first patient is dosed.
Predictions are calibrated against observed Phase II and Phase III outcomes, not just in silico benchmarks or power calculations.
Population PK/PD and virtual trial methods from Bajpai Labs, delivered on clinical development timelines with FDA-ready documentation.
You work with the pharmacometricians and simulation architects who built the platform, not a sales team relaying requirements to a black box.
The science behind the simulation.
Published pharmacometric methods composed with proprietary calibration from Bajpai Labs.
NONMEM and Monolix population models linking exposure to efficacy and toxicity across genotype, age, and co-medication subgroups.
Physiologically based pharmacokinetic simulation for hepatic, cardiac, and tumor tissue exposure under real-world dosing regimens.
Mechanistic hepatotoxicity models integrating DILIrank liability, reactive metabolite risk, and cumulative exposure thresholds.
Monte Carlo simulation of 5,000 to 10,000 virtual trials to estimate success probability, sample size, and interim boundary performance.
Dose optimization via target occupancy, tumor growth inhibition, and biomarker response curves calibrated to Phase I/II data.
Bayesian meta-analysis of published Phase III benchmarks to model biologic-experienced subpopulations and endpoint selection risk.
Methodology
Calibration Loop
Each model cycle incorporates published Phase III benchmarks and proprietary validation outcomes, not generic assumptions.
Accumulating trial data updates success probability and dose recommendations without restarting from scratch.
Sensitivity analysis and tornado charts expose the variables that actually drive trial failure, not just point estimates.
Pharmacometric rigor. Clinical development speed.
ClinicalSim combines population PK/PD expertise from Bajpai Labs with trial simulation depth that most biostatistics-only vendors lack.
- Decision-grade probabilities
Success probability, DILI risk, and dose rankings with confidence bounds. Not power calculations alone.
- PK/PD + clinical expertise
Cross-disciplinary team spanning pharmacometrics, toxicology, and clinical development strategy.
- Regulatory-ready output
FDA and EMA briefing addenda with exposure-response plots your regulatory team can submit directly.
- Direct line to leadership
You work with the simulation architects who built the models, not a sales team.
Simulation services
Four pipelines. One simulation engine.
From hepatotoxicity prediction through Phase III success probability, each service shares the same calibrated PK/PD infrastructure and senior pharmacometrics team.
All services- 00
Toxicity & DILI Prediction
Safety · Phase transitionStart hereMechanistic hepatotoxicity simulation integrating PBPK exposure, DILIrank liability, and population co-medication profiles. Delivers go/no-go recommendation before Phase II enrollment.
Engagements typically $125K–$350K per programSee capabilities - 01
PK/PD Dose Optimization
Exposure-response · oncologyPopulation PK/PD and tumor growth inhibition modeling to eliminate redundant dose arms and identify minimum efficacious exposure.
Engagements typically $200K–$400K per programSee capabilities - 02
Trial Success Probability
Virtual trial · biologicsMonte Carlo virtual Phase III simulation with Bayesian meta-analysis for endpoint selection, sample size, and subpopulation response.
Engagements typically $300K–$500K per programSee capabilities - 03
Adaptive Design Simulation
Interim boundaries · enrichmentInterim look optimization, futility boundaries, and enrichment strategy simulation for adaptive Phase II/III protocols.
Engagements typically $250K–$450K per programSee capabilities
by Bajpai Labs
Ready to simulate before you enroll?
30-minute intro call with the Bajpai Labs team. No pitch deck, just a scoping conversation about your Phase II or Phase III decision.