Expert role · CRO Commercial
Bid on feasibility you can show the sponsor.
A bid response drafted from a cited assessment rather than from an assertion — plus the pipeline, backlog, delivery-risk and KPI views the business-development team already keeps by hand.
A bid pipeline, narrowing to the bids worth writing.
The job · the CRO business-development or bid lead
Every CRO says the enrolment plan is realistic. Show it.
Bid defence is a credibility contest that is usually fought with assertions. Every bidder claims the enrolment assumptions are grounded and the country mix is right; almost none of them can hand the sponsor the evidence trail behind those claims, because it was assembled by a feasibility team under deadline and never written down in a form anyone else can check.
This workspace drafts the bid from a cited assessment — the enrolment realism, the country mix and the cost band all traceable to public records the sponsor can open themselves. Alongside it sit the pipeline, backlog and delivery-risk views that let the commercial team see which opportunities are worth the bid team's week. Every draft is reviewed and signed before it leaves.
What it covers
- Draft RFP and bid responses at the bid stage
- Track and forecast the bid pipeline and backlog
- Monitor delivery risk across the portfolio
- Generate periodic KPI snapshots
In the role registry
Bid pipeline, backlog, delivery-risk and KPI views for CRO business development
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.
RFP / bid response draft
A bid response drafted from the cited assessment, so the enrolment and country assumptions in the proposal come with the public records behind them attached.
Signed off by
a bid or business-development lead
Bid pipeline & backlog view
Qualified opportunities and backlog in one view, so the bid team's time goes to the opportunities with a defensible feasibility case behind them.
Signed off by
a commercial lead
Delivery-risk report
Portfolio delivery risk drafted from the operational-risk signals, so a commitment made in a bid can be checked against what the assessment already flagged.
Signed off by
a delivery or commercial lead
KPI snapshot
A periodic snapshot of the commercial metrics the team already reports, computed from the same records rather than re-keyed into a spreadsheet each period.
Signed off by
a commercial 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
A bid is a cost and a country mix with a date on it. This pillar is where all three come from.
Verdict
Knowing which risks the assessment already flagged is what stops a bid committing to something delivery cannot hold.
Cohort
Enrolment realism is the single claim a sponsor most wants evidence for, and the one most often asserted.
Commercial
Context for the sponsor's own commercial case, which is usually the reason the programme exists at all.
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 business-development or delivery 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.
Study Start-up
Country activation tracking and contract groundwork for the sites the assessment ranked.
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.