Pricing
Project-based pricing. No surprise invoices.
Each tier is a fixed-fee engagement with a defined simulation deliverable. Adaptive design extensions, multi-indication modeling, and real-time interim updates are quoted per scope.
Safety Simulation
$125K
3 weeks delivery
DILI prediction or single safety signal modeling for Phase II go/no-go
- PBPK exposure model
- Mechanistic DILI simulation
- Ranked dose scenarios
- Board decision deck
- Technical documentation
- Email support
Most popular
Dose Optimization
$300K
4 weeks delivery
PK/PD dose selection, exposure-response, and virtual trial arm comparison
- Everything in Safety Simulation
- Population PK/PD model
- Virtual trial Monte Carlo
- FDA briefing addendum
- Interim boundary options
- Two revision rounds
Enterprise
Custom
Flexible delivery
Phase III success probability, multi-indication, or adaptive design programs
- Everything in Dose Optimization
- Bayesian meta-analysis integration
- Real-time interim model updates
- Dedicated project manager
- DSMB briefing support
- Indemnification & SLAs
Add-ons: Real-time interim model updates, multi-indication simulation, CDISC data integration, and on-prem deployment for sensitive clinical data are quoted separately.
Frequently asked questions
- How accurate are ClinicalSim predictions?
- Across closed engagements, predictions for primary endpoints, safety signals, and trial success probability have shown 73 to 93 percent concordance with observed outcomes because models are calibrated against proprietary validation datasets and published Phase III benchmarks.
- What data do you need to start?
- Phase I PK datasets (rich or sparse), preclinical tox reports, planned protocol or dose regimen, and inclusion/exclusion criteria. CDISC SDTM preferred but not required. We can also start from published benchmark data for early feasibility.
- Can you support FDA or EMA meetings?
- Yes. On Dose Optimization and Enterprise tiers we deliver briefing document addenda with exposure-response plots, virtual trial operating characteristics, and sample size justification suitable for Type B and End-of-Phase II meetings.
- What's the typical ROI of a simulation engagement?
- Case studies show $2.4M to $16M in preserved capital per program via avoided failed trials, optimized sample sizes, and eliminated redundant dose arms. ROI depends on trial size and phase.
- Do you sign IP and confidentiality agreements?
- Always. We sign a mutual NDA before any technical discussion. All simulation models and reports are assigned to the client by default.
