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.

pmxstudio.ai mark
6wk
Maximum project timeline, from data delivery to a submission-ready report
6580%
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 · Commercial terms

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.

Scope a project
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
Common questions

What teams ask before they start.

Answered plainly, including the parts that are less convenient. If your question is not here, ask it on a scoping call and you will get the same kind of answer.

Is this a CRO with better marketing?

No, and the difference is structural rather than cosmetic. A CRO sells time, so the incentive runs toward more hours. We sell a defined deliverable at a fixed price, so the incentive runs toward finishing it well and quickly.

The practical consequence is that the senior scientist who scopes your project is the one who does the modelling. There is no pyramid underneath, and nobody is learning pharmacometrics on your programme.

How does pricing work?

A fixed price agreed before any code is written, against a scope agreed in the same conversation. The kickoff price is the final invoice.

The number depends on the question. A focused non-compartmental analysis is a modest, well-bounded piece of work. A population model with covariate analysis and a submission-ready report is considerably more. Tell us the question and you get a number and a description of exactly what it buys.

What happens if the analysis turns out to be harder than expected?

That risk sits with us, not with you. It is the point of fixed pricing. If a model resists convergence, or the covariate structure is more tangled than the data first suggested, we absorb the extra work.

What we will not do is quietly narrow the question to fit the budget. If the honest answer changes, you hear it while there is still time to act on it.

Where do the AI agents stop and the scientists start?

Agents do the slow, mechanical parts: assembling and checking datasets, generating diagnostic plots, drafting boilerplate report sections, and cross-checking outputs against the source data. They run in a controlled environment, not a public AI service, and your data is never used to train anything.

Every scientific judgement is made by a pharmacometrician. Model structure, covariate inclusion, what the diagnostics actually mean, and what goes in front of a regulator are decided by a person who signs their name to it. The agents make the work faster; they do not make the decisions.

Do we own the model, the code and the data?

Yes. Every engagement hands over the analysis dataset, the code, the model files, and a report with its tables and figures. Everything is generated from code, so it can be re-run, audited and extended.

Where the choice is ours we favour open tools, precisely so you are not dependent on a licence, or on us, to reopen your own work in two years.

Our data is sparse, or messy. Is that a problem?

Usually not one that prevents the work, though it changes what can be concluded. Sparse sampling still supports a population model; that is part of why the method exists.

What matters far more is that dosing and sampling times are reliable. Where they are not, we will tell you what can and cannot be concluded rather than papering over it. On real programmes a large share of the timeline goes into assembling and checking data rather than modelling, and we say so up front so the schedule is honest rather than optimistic.

Can you support a regulatory submission?

Yes. We prepare submission-ready population PK and exposure-response analyses documented to the standard FDA, EMA and PMDA reviewers expect, including the material an IND, NDA or MAA requires. We also help draft briefing documents and responses to questions that come back.

One honest caveat: acceptance depends on the whole dossier and the specific question, not on model quality alone. What we commit to is work that is documented, reproducible, and presented with its assumptions and limitations stated plainly.

When is the right time to engage you?

Earlier than most teams do. The highest-value moment is usually before a study is locked, when the design can still be changed so it produces data a model can actually use. The second best is as soon as a readout lands.

You do not need a modelling strategy to get in touch, only the question. If modelling is the wrong instrument for it, we will say so on the call rather than after you have paid for it.

How is confidentiality handled?

We sign NDAs as a matter of course, and will sign yours before reviewing any non-public material. Client results are never published without explicit written permission.

Analyses run in an isolated, access-controlled environment. Data is not sent to public AI services, is not retained beyond the engagement without agreement, and is not used to train models.

Have a study readout coming up?

Bring us the molecule, the dataset, and the regulatory question. Within five working days of a 15-minute scoping call, you have a one-page scope and a fixed-price, fixed-timeline proposal.

Scope a project
pmxstudio.ai

Pharmacometrics on a fixed price and a fixed timeline. Tell us the molecule and the question, and we will tell you what it takes.

Scope a project