Expert roles
Seven specialists that draft — and a human who signs.
Each role reads the same cited assessment and drafts the artefact its human counterpart would otherwise write by hand. Nothing it produces has standing until a qualified person signs it.
Draft → review → e-signature → record
The seven
The team you would otherwise hire or wait for.
These are the seven roles enabled in the product today. Each one is scoped to feasibility work — none of them invents data, and none of them approves its own output.
Protocol Design
a cited protocol synopsis
Drafts the trial protocol synopsis from the verdict, design, and cohort analyses — every claim cited.
Commercial Strategy
a commercial feasibility summary
Market size, standard of care, value-based price, patent runway, and risk-adjusted valuation scenarios.
CMO / VP R&D
a decision-gate memo
Portfolio-level valuation, decision-gate memos, and readout-risk framing for the go/no-go call.
Biostatistician
a statistical analysis plan
Statistical analysis plans, sample-size estimates, and data-monitoring-board materials.
Clinical Pharmacologist
a dose-selection memo
Dose-selection memos, exposure–response modelling, and drug-interaction risk.
Study Start-up
a country activation plan
Country activation tracking and contract groundwork for the sites the assessment ranked.
CRO Commercial
a bid response and pipeline view
Bid-pipeline and portfolio views for CRO business development teams.
The hand-off
Work moves as signed records, not as chat
One role's signed output is the next role's input. That is what makes the chain replayable months later — and what makes an audit possible at all.
The gate
Five steps, and the signature is step three.
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.
These are drafting assistants under human review.
They are not autonomous agents and they do not replace a qualified professional. The drafts carry no regulatory standing on their own; the reviewed, signed record does.
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.