"We have tox data and need a starting dose"
Interspecies scaling and PBPK to predict the human profile, translate on exposure rather than dose, and produce a starting dose and escalation scheme a reviewer can follow.
How we work
From the first question to a deliverable that holds up in front of a regulator.
Our approach
From your question to the submission
Every engagement follows the same four steps, whether the decision is internal or regulatory.
-
01
Start from the question
We begin with the decision you need to make, not with the data or the method: which candidate, which dose, which design, or what to answer a regulator.
-
02
Design the MIDD strategy
We define the analyses that will answer it, the data they need and what is realistic in your timeline. Scope, timeline and price are fixed in a written proposal, sent within 48 hours of first contact.
-
03
Execute
We do the modeling and simulation ourselves, in a GxP-compliant environment, with progress visible on your project dashboard.
-
04
Deliver toward submission
Results you can act on now, documented to submission standard, so the same work supports your internal decision and the regulatory file.
Start where you are
Sound familiar?
Most people arrive with one of these on their desk. You do not need a modeling strategy to get in touch, just the question.
"We cannot afford a second failed BE study"
For a complex generic, virtual bioequivalence by PBPK/PBBM tests the formulation and the study design in silico first, so the next study is sized on evidence.
"A reviewer asked why this dose"
Population PK and exposure-response that answer with evidence rather than assertion, including what happens to patients at the edges of the distribution.
"Our CRO sent data we cannot act on"
We turn study output into parameters and a decision. Better still, we look at the design first, so the study actually produces data a model can use.
"The IND needs a PK section and nobody owns it"
NCA, toxicokinetics, exposure-based safety margins and the human prediction, written to submission standard rather than assembled the week before.
"We are not sure modeling is worth it yet"
Then ask us. Sometimes the honest answer is that a simple non-compartmental analysis settles it, or that you need one more experiment instead of a model.
Project transparency
A live dashboard for every project
Every project gets its own secure, web-based dashboard. You can see where the work stands at any moment, and exactly when to expect each deliverable, without chasing a project manager.
- Scope, milestones and the agreed timeline
- Results, figures and reports as they are produced
- Real-time progress against each milestone
- Open questions and decisions, in one place
- Private, with access limited to your team
How we engage
Three ways to work with us
Each service area can be delivered in whichever form suits your team and your stage.
Milestone analysis
A defined question, a defined deliverable.
- Scope, timeline and deliverables agreed up front
- Model, code, dataset and report handed over
- Written so it can be re-run without us
Embedded scientist
Your quantitative function, part-time.
- Ongoing clinical pharmacology and DMPK input
- Sitting in on CRO and lab discussions
- Review of protocols and study designs before they are locked
- On call during a regulatory review cycle
Expert advice
A second opinion, without a project.
- A short engagement to sanity-check a plan or a model
- Review of a protocol or a CRO proposal before it is signed
- Due diligence support for a partner or investor
Quality and confidentiality
The standard behind every deliverable
The same standard applies whether the work is an internal decision or a regulatory submission.
Industry-standard tools
We work in the platforms regulators know and expect to see. Where a submission calls for a particular tool, that is the one we use.
GxP-compliant environment
Analyses run in a controlled, documented environment. Tool and package versions are recorded with each analysis and the work is under version control, so it re-runs to the same numbers long after the project closes.
Submission-ready by default
Datasets, code, models and reports are produced to submission standard from the first deliverable, with assumptions and limitations stated. Nothing has to be rebuilt when the work goes into a dossier.
Your data, under NDA
Client data is held under NDA on controlled storage, used only for the agreed work, and returned or destroyed on request.
Have a question on your desk?
Tell us where the programme is and what has to be decided. We will tell you what a model can settle, and what still has to be measured.