Expert role · Clinical Pharmacologist
The dose rationale, written down properly.
A dose-selection memo grounded in the pharmacology evidence, a modelling approach chosen for the data you actually have, a sampling schedule that respects patient burden, and an interaction-risk narrative from the target and off-target screens.
Exposure against response, with the selected dose marked.
The job · the clinical pharmacology lead who has to justify the dose
Everyone knows the dose. Almost nobody has written down why.
The dose that goes into the protocol is usually defensible and usually undocumented — carried forward from preclinical work and a conversation, with the rationale reconstructed later when a reviewer asks for it. The reconstruction is where the time goes, and it is also where the gaps show up: the interaction risk nobody screened, the sampling schedule that was set by convention rather than by what the model needs.
This workspace drafts the memo up front. It reads the target and pharmacology evidence, recommends a modelling approach appropriate to the shape of the data rather than the most sophisticated one available, and lays out the sampling schedule and interaction risk alongside the dose. A clinical pharmacologist reviews the reasoning and signs it.
What it covers
- Draft dose-selection memos with the rationale attached
- Recommend an exposure–response or popPK modelling approach for the available data
- Optimise the PK sampling schedule under patient-burden constraints
- Assess and narrate drug–drug interaction risk
In the role registry
PK/PD modelling, dose-selection memo, interaction risk
What it drafts
Deliverables — drafts, until signed.
Each artefact arrives with its citations attached and its status explicit. Nothing below is final until a named human signs it.
Dose-selection memo
The dose and the argument for it, drafted from the pharmacology evidence — target engagement, binding affinity, and what the structural and off-target picture implies for the window.
Signed off by
a clinical pharmacologist
Exposure–response model recommendation
A modelling approach proposed for the data that exists — popPK, exposure–response, or neither yet — so the plan is proportionate to the evidence rather than to the ambition.
Signed off by
a clinical pharmacologist or modeller
PK sampling schedule
A sampling schedule optimised against what the model needs and what a patient will realistically tolerate — the trade-off made explicit instead of settled by convention.
Signed off by
a clinical pharmacologist
Drug–drug interaction risk narrative
Interaction and off-target risk written up from the pharmacology screens, so the risk is in the protocol's reasoning rather than discovered during review.
Signed off by
a clinical pharmacologist
What it reads
It drafts from the assessment, not from memory
The role has no private knowledge. Every claim it writes traces to an analysis in one of the six pillars, and through that to a public source record.
Rationale
The pharmacology pillar is the memo's evidence base — what the asset binds, how well, and what else it touches.
Design
Dosing conventions in an indication are set by what has already been run in it.
Cohort
A sampling schedule that ignores who is actually in the trial is a schedule that gets amended.
How it is governed
A role drafts. A human signs.
This is the part that matters, so it is stated without hedging: the role has no authority to approve anything, and its output has no standing until a qualified person puts their name on it.
The role drafts.
It produces a draft deliverable with its citations attached. A draft has no standing: it is not approved, not final, and not actionable. The role has no authority to change it into any of those things.
A named human reviews.
The draft lands as a task for a specific person on your team. They can edit it, reject it, or send it back for a re-draft against the current evidence. Nothing moves until someone with a name has read it.
Sign-off is a Part 11 electronic signature.
Approval is recorded as a 21 CFR Part 11 electronic signature — attributable to an authenticated identity, time-stamped, and bound to the exact version of the record that was signed.
The whole chain is hash-chained.
Every draft, edit, review and signature is appended to a tamper-evident, hash-chained audit trail. It is reproducible and exportable, so your QA team can reconstruct who approved what, on what evidence, and when.
Stale approvals are flagged.
If the underlying evidence later changes, the signed decision is automatically flagged for re-review. Nothing stays approved on data that has since moved.
This role does not replace a qualified clinical pharmacologist.
It is a drafting assistant working under human review. It is not an autonomous agent, it does not make regulatory decisions, and its drafts carry no regulatory standing of their own — the signature does.
Where it goes next
The signed record is the hand-off
Roles do not message each other informally. One role's signed output is the next role's input, which is why the chain can be replayed.
The rest of the team
Seven roles, one governed record
Protocol Design
Drafts the trial protocol synopsis from the verdict, design, and cohort analyses — every claim cited.
Commercial Strategy
Market size, standard of care, value-based price, patent runway, and risk-adjusted valuation scenarios.
CMO / VP R&D
Portfolio-level valuation, decision-gate memos, and readout-risk framing for the go/no-go call.
Biostatistician
Statistical analysis plans, sample-size estimates, and data-monitoring-board materials.
Study Start-up
Country activation tracking and contract groundwork for the sites the assessment ranked.
CRO Commercial
Bid-pipeline and portfolio views for CRO business development teams.
See a verdict you can actually check.
Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.