Expert role · Study Start-up
Activation groundwork for the sites that were ranked.
Country activation tracked and forecast, contracts redlined against your template, consent forms QC-screened for the elements they are missing, and outreach drafted to the investigators the site analysis put at the top.
Countries activating in sequence, not all at once.
The job · the start-up or country lead who owns first-patient-in
The timeline slips in start-up. It rarely slips anywhere else.
Feasibility usually ends at a site list. Start-up begins with the same list and immediately has to turn it into contracts, consent forms, ethics submissions and outreach — in a specific order, per country, with a date attached. The ranking that came out of feasibility is rarely carried into any of it, so the sites that were chosen for their track record get activated in whatever order the paperwork happens to allow.
This workspace picks up the ranking and does the groundwork against it: activation milestones and an ETA per country, contract redlines against your template, a consent-form screen for the required elements, and outreach drafts addressed to the investigators the assessment actually ranked. Your start-up lead reviews and signs each one.
What it covers
- Track country activation milestones and forecast ETAs from readiness signals
- Redline site contracts against your template
- QC-screen informed-consent forms for required elements
- Draft investigator outreach for the ranked sites
In the role registry
Country activation tracking, contract redlines, ICF QC, investigator outreach
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.
Country activation tracker & ETA forecast
Activation milestones per country with a forecast ETA from the readiness signals — so the plan says which country is on the critical path, not just that start-up is under way.
Signed off by
a start-up or country lead
Site contract redline
Draft redlines against your own contract template, so the negotiation starts from a marked-up document rather than from a blank comparison.
Signed off by
a contracts lead, with legal
Informed-consent QC screen
A screen of the consent form against the elements it is required to contain, flagging what is missing for a human to resolve — a check, not an approval.
Signed off by
a start-up lead, with the ethics reviewer
Investigator outreach draft
Outreach drafted to the investigators the site and investigator selection analysis ranked, with the reason each one was ranked attached.
Signed off by
a start-up or country lead
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.
Where & How
This pillar is the role's input in full — the map, the ranking, the competition for the same patients, and the cost band.
Cohort
Where the eligible patients actually are is what makes a country worth activating first.
Design
A site running three competing trials in the same indication is a start-up risk before it is a recruitment one.
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 start-up, contracts or regulatory professional.
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.
Clinical Pharmacologist
Dose-selection memos, exposure–response modelling, and drug-interaction risk.
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.