Phase 3 dose rationale 6 weeks
Oncology · exposure-response
Exposure-response for efficacy and safety, and a dose-justification memo for Project Optimus.
The evidence behind your next development decision
A forty-two-second film. The evidence behind your next development decision: pharmacometrics and MIDD, from first-in-human to filing. Every milestone raises a question, each shown with its analysis figure: setting a first-in-human dose you can defend, turning Phase 1 data into a Phase 2 dose with a population PK model and its visual predictive check, deciding which DDI studies you still need, and dosing children with less pediatric data. Each package ends with the document you file: a briefing-document dose justification, a population PK and exposure-response report, an ICH M15 assessment table, and the datasets, define.xml and code. Fixed price and a guaranteed date, up to 6 weeks from a clean dataset. A senior pharmacometrician, augmented by our own AI agents that prepare data, draft code and reproduce every analysis but never produce results or make decisions; a second pharmacometrician reviews every model. It ends with an invitation to discuss your program in a 15-minute call.
Senior-led modeling from first-in-human to filing, at a fixed price and on a guaranteed date.
Packages built around
- ICH M15
- ICH E14/S7B
- ICH M12
- ICH E11A
- ICH M13A
- FDA Project Optimus
What we solve
One development question per package, ending with the document you file.
First-in-humanSet a first-in-human dose you can defendTranslational PK/PD
Phase 1Make the QT case from Phase 1 dataConcentration-QTc · ICH E14/S7B
Phase 1–2Decide which DDI studies you still needPBPK · ICH M12
End of Phase 2Choose and defend the Phase 3 doseExposure-response · Project Optimus
PediatricsDose children with less pediatric dataPopPK with maturation · ICH E11A
Life cycleChange formulation or route without losing exposurePopulation PK bridging
FilingMake the dossier's MIDD evidence review-readyNDA · BLA · MAA
GenericsSize the BE study before you run itBE study design · ICH M13A
Any stageFind out if an inherited model will hold upModel takeover and audit
All packages, special populations and the MIDD Strategy Sprint →
A different way to buy pharmacometrics
Classical CROpmxstudio.ai
Time
Weeks of contracting before work starts. End dates move.
Proposal within 48 hours. Delivery date written into the contract.
Cost
Hourly billing and change orders.
Fixed price per package, paid at milestones.
Risk
Delays and follow-up questions are billed to you.
Late weeks are credited. Agency questions on our analyses are answered free.
Expertise
A project manager stands between you and the modeler.
You work directly with the senior pharmacometrician who does the modeling.
We guarantee the date and the documentation standard, never regulatory acceptance.
A senior pharmacometrician, augmented by our own AI agents
- Agents. Custom-built and running on our own servers, they prepare data, draft code and reproduce every analysis. They never produce results or make decisions.
- Controls. Client data never leaves our servers. Every run is logged and reproduced, and the analysis plan is approved before modeling starts.
- Standards. Every package follows the ICH M15 framework, with CDISC datasets and eCTD-ready reports.
DescriptiveMechanistic and predictive
- NCA and TFLsStudy reports and CSRs
- Population PKCovariates, special populations
- Exposure-responseEfficacy, safety, C-QTc
- Mechanistic modelsTMDD, disease, biomarkers
- PBPKDDI, organ impairment, pediatrics
- Virtual trialsDesign and dose before the trial
Selected work
Led by Raphael Bilgraer, described anonymously.
Phase 1b dose projected 6 weeks
Rare disease · population PK
Population PK from SAD/MAD data and the dose rationale for the end-of-Phase-1 meeting.
TQT waiver accepted 5 weeks
Cardiac safety · C-QTc
Pre-specified concentration-QTc analysis of pooled Phase 1 data, including the CSR section.
[X] wk
Median time from analysis-ready data to report
[X]%
Delivered on or before the guaranteed date
[N]
Projects delivered
We reproduced [N] published popPK and PK/PD models.
Pre-specified selection protocol and acceptance criteria, with failures reported next to successes. See the benchmark.
Who does the work
A senior expert does the modeling. A second pharmacometrician follows every project, and specialists join when needed.
Raphael Bilgraer
PharmD, PhD · Founder, lead pharmacometrician
15+ years of experience across big pharma and leading CROs in quantitative clinical pharmacology.
Full background →Discuss your program
A 15-minute call with the pharmacometrician who would do the work. A fixed proposal follows within 48 hours.