Cardinal checks them — against 587,000 real trials — before you write a single section.
Three parameters — indication, phase, N. Nothing confidential, nothing uploaded. Benchmarked live against the trial registry. You will have an answer before you finish your coffee.
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Want Cardinal to run the remaining five dimensions against your actual protocol?
Claim your free assessment →An amendment is never really a documentation failure. It is a design decision — an eligibility rule, an endpoint, a sample size — that no one had the evidence to challenge at the time. By the time it surfaces in enrollment or review, it costs six figures and three months to undo.
Sample size, eligibility, and endpoint choices are set by convention and committee memory. The precedent that would test them sits in a registry nobody queries mid-design.
A sample size stated one way in the objectives and another in the statistics. An endpoint defined twice, differently. Manual review misses them; reviewers do not.
Hard questions from biostatistics, ethics, and regulatory arrive for the first time in an actual review — the most expensive possible place to discover a flaw.
Upload your Investigator's Brochure. Cardinal returns a complete, ICH M11-aligned draft — then keeps working: benchmarking your design against precedent, checking the document against itself, rehearsing your review, and generating everything downstream.
Cardinal is built around the workflow your medical writers and clinical operations team already know — not a new paradigm to learn. It just doesn't stop at the draft.
Compare design options in Design Studio before a section is written — sample size, eligibility, and endpoint choice benchmarked against thousands of matched trials.
Upload your IB and Cardinal drafts the full protocol, while Quality Scoring and the Consistency Engine check every section — and each other — as you go.
Reviewer Simulation raises the questions a real review would, Amendment Risk flags what's likely to cost you later, and the SAP, ICF, synopsis, and EDC spec generate straight from your protocol.
Cardinal does not generate protocols from a blank slate. Every endpoint suggestion, design choice, and safety framework is grounded in the precedent of similar trials — this is what powers Design Studio, surfaced from a structured index of past clinical research.
When ACR20 was the standard primary endpoint for Phase 2 RA trials, Cardinal would suggest it. Today, ACR50 has overtaken it — and Cardinal reflects that shift, with the data, the evidence grade, and the confidence range to back it up.
This is the difference between a writing tool that writes for you and a clinical development intelligence platform that thinks alongside you — and never makes the final call for you.
Cardinal is not a writing assistant. It designs, drafts, validates, and pressure-tests the protocol — then generates everything downstream of it. Every capability is live; every output is traceable.
Compare two or more design options before authoring begins — sample size, eligibility, and endpoint choice, each benchmarked against a matched cohort of real trials with a confidence range attached.
Mechanism, dosing, PK/PD, and safety pulled verbatim from your uploaded Investigator's Brochure. Never fabricated, never approximated.
Every section scored 0–100 on completeness, clarity, and regulatory alignment — recalculated automatically on every save.
Catches cross-section contradictions before they reach review — sample size, treatment duration, and endpoint definitions checked against themselves everywhere they appear.
Scores overall amendment risk and surfaces specific flags across five dimensions — eligibility, endpoints, statistical design, schedule of assessments, and operational burden. Every flag includes the protocol evidence and a concrete recommendation.
Six expert review personas — clinical, biostatistics, operations, data standards, ethics, and regulatory — read the protocol and raise the questions a real reviewer would ask first.
From flagged risks to a complete, ICH E6(R2) / 21 CFR 312.30-compliant Protocol Amendment document in one click. Disputed flags are pre-populated and locked; accepted flags are excluded. Editable Word output ready for expert review.
Current FDA and EMA guidance, ICH guidelines, and precedent cases, surfaced automatically against whichever section you're writing — updated monthly.
The full distribution — not just a single score — for enrollment size, duration, and screen-failure rate, filterable by phase, sponsor type, region, and year.
Upload a revised protocol for the same drug and indication and Cardinal automatically links it as v2, v3, and so on. A visual score trend shows how amendment risk changes across each revision — so you can see immediately whether changes improved the picture or introduced new exposure.
Ask any question about an uploaded protocol — eligibility rationale, Schedule of Assessments design, statistical justification. Every answer is grounded in the actual protocol text and its risk flags, not general knowledge. Validated across 40 clinical question types by persona; scored 4.08/5.0 for protocol-specificity.
Upload competitor or historical protocols as benchmarks alongside your own. Cardinal keeps them in a separate library, scoped entirely to your organization — no other team can see or query your library. Compare risk profiles across programs without ever exposing sponsor data.
Half a million trials have already been run. Their designs, their endpoints, their failures — all of it public, and almost none of it available at the moment someone sits down to design the next one.
Merquell exists to close that gap. Not by replacing medical writers and clinical operations teams, but by giving them a platform that checks the decisions, not just the prose.
Merquell Technologies Inc., federally incorporated in Canada. Headquartered in Toronto, Ontario.
Working with a select group of design partners to validate Cardinal and shape the roadmap ahead of general availability.
Sponsors and CROs designing and authoring clinical trial protocols — from first-in-human through Phase 3, at emerging biotechs and established organizations alike.
ICH M11 compliant generation. US FDA, EMA, and Health Canada awareness built into the core architecture.
Cardinal never ranks or recommends an option, and never decides for you. It shows the evidence, names its source, and leaves the call — and the sign-off — with your team. Every score traces back to a dataset, a cohort size, and a confidence range.
Your Investigator's Brochures and protocol inputs are never used to train any language model, and are accessible only to your organization. Confidentiality is the default, not a setting.
Your IB and protocol inputs are encrypted in transit and at rest, processed under strict data agreements with the enterprise infrastructure that powers generation. AES-256 at rest.
Every generated section traces back to its source — IB extract, precedent reference, or user input. Designed for regulatory traceability from day one.
Built with awareness of FDA, EMA, PMDA, and Health Canada regulatory frameworks. Generation logic adapts to regional submission requirements.
Every database query is scoped to your organization at the row level. A CRO managing 40 sponsors cannot expose one sponsor's protocol intelligence to another — not through a misconfigured permission, not through a shared session, not through an indirect query. The architecture enforces it; policy alone does not. If you are one organization, you see only your data. Full stop.
We run Cardinal against one of your live protocols and walk you through everything it flags — design risks, contradictions, and the questions a reviewer would ask. Under mutual NDA, before anything is shared.
Mutual NDA first. Thirty minutes with the founder — no sales team, no email sequence.
You will hear from Pavan.kumar@merquell.com within two business days, with a mutual NDA and a link to book your thirty minutes.
Nothing else — no newsletter, no drip sequence.