For emerging biotech
Spend the runway on the trial that can actually work.
A first-in-class asset and eighteen months of cash does not leave room for a protocol that was optimistic about enrolment. Pressure-test the design, the cohort, the sites and the commercial case against public evidence — before the protocol locks.
One asset, one shot, a finite runway.
The situation
You get one attempt, and the protocol decides it.
A small sponsor cannot absorb a failed trial and re-run it. Almost every decision that determines the outcome — endpoint, eligibility, comparator, countries — is made before the first patient is screened, by a team that does not have a feasibility department.
- Pillars scored before you commit
- 6
- Analyses behind the verdict
- 30+
- No data room, no site survey to wait on
- Public data
What happens today
The design gets set before anyone checks it.
Not through negligence — through sequencing. The protocol has to exist before the CRO can quote it, and by the time feasibility feedback arrives the design is already the thing being priced.
Feasibility arrives after the design is fixed
The CRO’s feasibility work starts once there is a protocol to cost. Findings that should have changed the eligibility criteria instead become amendments after start-up.
Eligibility is written for cleanliness, not recruitability
Each criterion is individually defensible. Stacked together they can cut the eligible pool to a fraction of the indication prevalence — and nothing in the drafting loop measures that.
Prior failures in the indication go unexamined
Trials that already failed with a similar design are public record. Reading them systematically is the highest-yield hour available, and it is almost never budgeted.
The commercial case is a slide, not an analysis
Market size and price often come from a banker’s deck. If the value-based price cannot clear the standard of care, that is worth knowing before the trial, not after it reads out.
What you get instead
The whole case, checked before you commit.
The scientific case, checked
Target validation, binding affinity, off-target and interaction risk, and structural viability, read from public target and pharmacology evidence rather than from your own deck.
Your design against the indication norm
How your endpoints, comparator and duration compare with what has actually been run — and with the comparable trials that failed, and their stated reasons.
What your eligibility criteria really cost
Cohort sizing and eligibility complexity: how many patients exist, and how much each criterion narrows the pool you can actually recruit from.
Where to run it, and what it costs
Countries and sites ranked by investigator track record and competing-trial density, with an operational cost band built from public benchmarks.
Whether it is worth it if it works
Market sizing, value-based price against the standard of care, patent runway, and a risk-adjusted eNPV — the argument your next raise will be judged on.
Deliverables your team can sign
A protocol synopsis, a statistical analysis plan, a dose-selection memo and a go/no-go memo, drafted with citations and approved with a Part 11 e-signature by your own people.
What runs, and who drafts
The scope for this job
A single-asset sponsor is the one reader who needs all six pillars: nobody else in the organisation is checking the science, the design, the cohort, the operations and the commercial case at the same time.
Pillars involved
How it runs
A molecule and an indication is enough to start.
Describe the study
Upload a draft protocol or synopsis — or just name the molecule (or its drug class) and the indication. The platform reads out phase, endpoints and eligibility criteria and asks about what it could not find.
The assessment runs
More than 30 analyses across six pillars are computed against around 50 live public sources, with every figure cited to the record and snapshot it came from.
Decide, then draft
Read the go/no-go verdict and the risks that could still change it. When you commit, the expert-role workspaces draft the protocol synopsis, SAP and dose memo from the same cited evidence — for your team to review and sign.
What lands on your desk
A decision packet, not a dashboard.
Everything below is exportable and citation-linked, so it can go straight into a board pack, a partner conversation or a raise.
What lands on your desk
Six-pillar assessment + go/no-go memo + drafted deliverables
- A go/no-go recommendation with a directional probability of success and the risks that would change it.
- A design read-out: your protocol against the indication norm, against comparable trials, and against the statistical power the sample size actually buys.
- Cohort sizing with the eligibility burden made explicit, criterion by criterion.
- A country and site shortlist with competing-trial density and an operational cost band.
- The commercial case: market size, value-based price, standard of care, patent runway and risk-adjusted valuation.
- Drafted, cited deliverables — protocol synopsis, statistical analysis plan, dose-selection memo — signed off by your team under 21 CFR Part 11.
Honest limits
Where this stops
What this does not do for you. Naming it here is cheaper for both of us than finding it in a procurement review.
Decision-support for trial design, not a medical device and not a regulatory submission. Your medical, regulatory and legal judgment still governs.
It reads public evidence. Your unpublished preclinical package, your CMC position and your regulatory correspondence are not in it — bring those to the same table.
The probability of success is directional and shown with its assumptions. Treat it as a structured argument, not a number to put in a term sheet.
Drafted deliverables are drafts. They are written to be reviewed, edited and signed by a qualified person on your team — the sign-off step is not optional decoration.
Cost bands are built from public benchmarks and will not match a specific CRO quote. They are for sizing the decision, not for contracting.
Questions
The ones you would ask first
We do not have a protocol yet. Is it too early?
That is the best time. A molecule — or even just its drug class — and an indication is enough to run the assessment, and findings that arrive before the design is locked are the ones that can still change it.
How is this different from asking our CRO?
A CRO prices the protocol you hand it. This assesses whether that protocol is the right one, from public evidence, before the quote — and gives you the citations to have that conversation on equal footing.
Does it replace our clinical and regulatory advisors?
No. It does the evidence-gathering they would need days to do, and presents it cited so their time goes into judgment rather than into literature searches.
Will the output stand up in a board pack or a raise?
Every figure links to the public record it was read from, with a snapshot date, and every run carries a tamper-evident audit trail. That is what makes an outside reader able to check it instead of having to trust it.
What if the answer is no-go?
Then you have found that out before spending the runway, with the reasons written down. A well-evidenced no-go on one indication is often the start of the argument for a better one.
Check the trial before you fund it.
Send us a draft protocol — or just a molecule and an indication. We’ll return a fully cited six-pillar assessment and a go/no-go verdict you can take to your board.