A pharmacometrics studio

Submission-ready pharmacometrics, on a fixed timeline.

We are pharmacometricians and clinical pharmacology scientists who build the models behind dose selection, exposure-response and regulatory submissions. A team of proprietary agents, each specialised in one step of the pharmacometrics workflow, runs alongside us. That is how every project reaches a submission-ready report within six weeks of data delivery, at a fraction of a classical CRO budget.

Scope a project See what we deliver
pmxstudio.ai mark
6wk
Maximum project timeline, from data delivery to a submission-ready report
65–80%
Lower cost than the same project scope at a classical CRO
30+
Pharmacometric submission packages led by the team
0
Change orders or budget overruns; the kickoff price is the final invoice
Why teams hire us

Three commitments behind every engagement.

01

Fixed price. Fixed timeline.

Scope, deliverables and price are fixed before kickoff, with no time-and-materials creep. Because our agents carry the repeatable work, that price typically lands three to five times below a comparable CRO engagement. The timeline is just as firm: no more than six weeks from data delivery to a submission-ready report.

02

A specialist agent for every step.

Our core innovation is a team of proprietary agents, each one specialised in a single step of the pharmacometrics workflow: dataset assembly, control-stream drafting, diagnostics, QC, reporting. Configured to your data and SOPs, they run alongside our scientists and do the repeatable work faster and more consistently than a human team. Modelling decisions and interpretation stay with our experts.

03

Submission-ready by default.

Every deliverable is built to the standard of a regulatory package: CDISC-aligned, traceable, version-controlled, archivable. Because the agents draft to one consistent standard, reports come back clean, with far less editing back-and-forth before sign-off.

How we differ

A studio model, not a CRO and not a freelancer.

Most pharmacometric work today is done either inside a large CRO, on time-and-materials with a junior-heavy team, or by a single independent consultant. Neither model gives you senior delivery, fixed pricing, and modern tooling in one place. We do.

pmxstudio.ai

The studio model

Traditional CRO

Large vendor

Independent consultant

Solo freelancer

In-house pharmacometrics

If you're hiring
Pricing model
Fixed price, fixed timeline
Time & materials
Hourly or T&M
Salary + overhead
Team you get
Senior scientists, same team throughout
Pyramid: partner pitches, junior delivers
One person, single point of failure
Hard to attract and retain
Tooling
Custom AI agents for data, code, QC
Generic SOPs, manual workflows
Personal stack, ad-hoc
Whatever the team built
Submission experience
FDA, EMA, PMDA, Health Canada, MHRA
Yes, varied by team
Sometimes
Builds slowly
Time to start
Two weeks from first call
Months
Days to weeks
3–6 month hire
Project timeline
Six weeks or less, data to report
Several months
Variable, often slow
Competes with other work
Best when
You need senior, defined-scope deliverables fast
Multi-year, multi-program contracts
Narrow, short, low-stakes asks
You have continuous demand
What we deliver

Quantitative pharmacology, scoped as a project.

From first-in-human dose justification through end-of-Phase-2 dose selection and regulatory submission. Each engagement is a defined package: datasets, code, model, report.

PopPK

Population PK modelling

Structural model development, covariate analysis, simulation-based diagnostics, bootstrap, VPC. For SAD/MAD, dose-finding, and Phase 2/3 PopPK reports.

PK/PD

PK/PD & exposure-response

Continuous and categorical endpoints, time-to-event, indirect-response. Dose-justification narratives that hold up to regulatory scrutiny.

MIDD

Model-informed drug development

Clinical trial simulation, dose selection, adaptive design support, pediatric extrapolation. Decision-grade analyses for development teams.

REG

Submission packages

End-to-end pharmacometric write-ups, CTD modules 5.3.3 / 5.3.4, reviewer-ready datasets and code archives. Written to hold up at agency review.

QT

Concentration-QTc analysis

Standalone C-QTc analyses to support TQT waivers per ICH E14 Q&A. Pre-specified analysis plans, mixed-effects modelling, sensitivity analyses.

PBPK

PBPK & physiological modelling

DDI prediction, organ-impairment scenarios, pediatric scaling. Built in PK-Sim/MoBi with verification against observed clinical data.

See full services & how we work
How we work

Four steps, scoped before we start.

A predictable engagement model. You see the scope, the deliverables, and the date before any code is written.

01 · Scope

Scientific scoping call

We review the question, the data, the regulatory context. You receive a one-page scope and a fixed-price proposal within five working days.

02 · Data

Dataset assembly

Our agents assemble and version the analysis-ready datasets, CDISC-aligned and fully traceable. Senior pharmacometricians sign off.

03 · Model

Modelling & analysis

Structural and stochastic model development, covariate analysis, diagnostics, simulation. Weekly written updates with run records.

04 · Deliver

Submission-ready package

Report, datasets, code, run archive, and a working session with your team. Built to be lifted straight into your submission.

Recent engagements

What a fixed-price project looks like.

Anonymized vignettes from recent work. Every engagement closes with a written report, an analysis dataset, a code archive, and a working session with your team.

Oncology · Phase 2→3 Exposure-response

Pivotal-trial dose selection for a solid-tumour asset.

Integrated Phase 1/2 PK and efficacy/safety data into an exposure-response analysis to support Phase 3 dose-and-schedule selection. Output included a dose-justification memo aligned with FDA Project Optimus expectations.

Duration
6 weeks
Deliverable
E-R report + memo
Rare disease · FIH PopPK + simulation

First-in-human PopPK and Phase 1b dose projection.

Built the PopPK model from SAD/MAD data, simulated multiple-dose regimens for the Phase 1b cohort-expansion, and drafted the dose-rationale section of the end-of-Phase-1 briefing document.

Duration
6 weeks
Deliverable
PopPK + briefing-doc text
Cardiac safety C-QTc

Concentration-QTc analysis supporting a TQT waiver.

Standalone C-QTc analysis on pooled Phase 1 data per ICH E14 R3 Q&A. Pre-specified linear mixed-effects model, sensitivity analyses, supratherapeutic predictions, and the CSR section. Waiver request accepted at the next interaction.

Duration
5 weeks
Deliverable
C-QTc report + CSR section

Have a study readout coming up?

Bring us the molecule, the dataset, and the regulatory question. Within five working days of a 30-minute scoping call, you have a one-page scope and a fixed-price, fixed-timeline proposal.

Scope a project