How we work

How a project runs

Direct access to the pharmacometrician, full visibility, and response times written into the proposal.

Service levels

48 hFixed proposal after the call
1 dayReply to any question, on business days
48 hAdd-on simulations on a delivered model

Step by step

A written update every week. Meetings only when a decision is due.

  1. 01

    Scoping call

    The question, the data and the regulatory context, with the pharmacometrician who would do the work.

  2. 02

    Fixed proposal

    Scope, deliverables, delivery date and price.

  3. 03

    Analysis plan

    Question, context of use and acceptance criteria, approved before modeling starts.

  4. 04

    Modeling

    Every run logged and reproduced; every decision recorded.

  5. 05

    Report

    Report, M15 assessment table, code and data. Revisions until you sign off.

  6. 06

    Agency interaction

    Briefing-document sections and support through the meeting.

The project page

Status, run log, decisions and deliverables in one place, with an optional Slack or Teams channel.

projects.pmxstudio.ai / pmx-101-er
Status
PMX-101 · Exposure-response for Phase 3 dose
Modeling · week 4 of 6 · on track for the guaranteed date
Next milestone
MAR and assessment table
Due 14 May · payment milestone 2 of 2
Run log
  • run 021 · E-R efficacy, Emaxverified
  • run 020 · E-R safety, logisticverified
  • run 019 · E-R efficacy, linearre-executing
Decisions log
  • D-11 Cavg,ss as exposure metric, per MAP §4.2signed
  • D-12 Exposure for 3 patients without PK samples predicted from dose historysigned
Deliverables
  • MAP v1.2 (approved)PDF · DOCX
  • Analysis dataset v3 + define.xmlXPT
  • Interim results memoPDF
Open questions
  • Q-04 Dose-reduction dates for site 112?with you
  • Q-05 Confirm the safety endpoint definitionanswered

Working with your CRO

Keep your CRO for operations and data management; bring the modeling to us.

Formats we accept

SDTM, ADaM or raw

With specifications. We build and double-program the analysis dataset.

What starts the clock

Agreed, analysis-ready data

The delivery date runs from receipt of the data agreed in the plan. Gaps are flagged in writing before the clock starts.

Before you send anything

Data-readiness checklist

Dosing, sampling times, BLQ flags and units.

Available on request.

Continuity

  • A second pharmacometrician follows every active project.
  • A handover package at every milestone: data, code, logs and the current draft.
  • Everything is yours, and can be re-run by anyone.

Talk to the person who would do the work

A fixed proposal follows within 48 hours.

Book a call