Merquell is the AI authoring platform for clinical trial protocols. We combine your Investigator's Brochure with structured precedent intelligence to generate ICH M11-compliant Phase 2 protocol drafts. Your medical writers refine — instead of recreating from scratch.
Clinical trial protocols are still authored the way they were in 2005 — in Microsoft Word, passed between teams via email, rebuilt from scratch each time. The cost is measured in months of medical-writer time per protocol, and the loss is recoverable.
Medical writers spend the first two weeks searching for templates and adapting prior protocols — tribal knowledge that walks out the door when senior writers leave.
Background, rationale, safety monitoring, and statistical frameworks are functionally identical across protocols, yet manually rewritten for each new study.
Endpoint conventions, design patterns, and approved language live across thousands of past protocols. Until now, that precedent has been inaccessible at the moment of authoring.
Upload your Investigator's Brochure. Provide 25 structured inputs covering design, population, and endpoints. In under five minutes, Cardinal — our AI authoring engine — returns a structured 80-page ICH M11-compliant draft with schedule of assessments, statistical framework, and safety monitoring sections intact.
Cardinal is built around the workflow your medical writers already know — not a new paradigm to learn.
Drop in your Investigator's Brochure. Cardinal extracts mechanism, dosing, PK/PD, and safety data — verbatim, never fabricated.
Twenty-five structured inputs covering phase, design, blinding, randomization, endpoints, sample size, and population.
Editable Microsoft Word output, formatted to ICH M11, with section structure, SoA tables, and statistical framework intact.
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 — 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 to back it up.
This is the difference between an AI tool that writes for you and an AI platform that thinks alongside you.
Cardinal is not a writing assistant. It is an AI-native protocol authoring platform — built from first principles around how clinical research teams actually work.
Mechanism, dosing, PK/PD, and safety pulled verbatim from your uploaded Investigator's Brochure. Never fabricated, never approximated.
Available nowCardinal surfaces endpoint patterns, statistical approaches, and design benchmarks from past Phase 1–3 trials registered on ClinicalTrials.gov.
Roadmap · Q3 2026Catches cross-section contradictions before they reach review — treatment duration vs. SoA, endpoint definitions vs. statistical sections.
Roadmap · Q2 2026Output is a properly formatted, section-structured .docx — not raw text. Drops into your existing review workflow from day one.
Available nowMulti-user review, version control, and threaded comments for your full authoring team. No more emailing Word files between fourteen people.
Roadmap · Q3 2026Protocol structure, section ordering, and terminology aligned to the ICH M11 guideline — the current international standard for clinical protocols.
Available nowMerquell is an AI company building authoring tools for the world's most consequential documents — clinical trial protocols, regulatory submissions, investigator's brochures.
Today, these documents are still authored in Microsoft Word, passed around by email, and reviewed through processes built on tribal knowledge accumulated over decades. We exist to change that — not by replacing medical writers, but by amplifying them with AI built to the rigor of the science they produce.
Cardinal is our first product. Built from first principles, with input from medical writers and clinical operations leaders. We start with protocol authoring — and build toward a future where every step from IND preparation to regulatory submission has proper AI-native tooling.
Merquell Technologies Inc., federally incorporated in Canada. Headquartered in Toronto, Ontario.
Pre-launch. Working with select design partners to validate Cardinal and shape the roadmap. Not yet generally available.
Series A–C biotechs (20–150 employees) and clinical research organizations requiring Phase 1–3 protocol authoring.
ICH M11 compliant generation. US FDA, EMA, and Health Canada awareness built into the core architecture.
Pharmaceutical-grade software requires more than a wrapper around a language model. Cardinal is engineered for the security, accuracy, and auditability that regulated research demands.
Cardinal's generation engine is built on Anthropic's Claude — a state-of-the-art model designed with safety and accuracy as core principles.
Your IB and protocol inputs are encrypted in transit and at rest. SOC 2 Type II framework currently in development with target audit completion by Q4 2026.
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.
We are working with a select group of design partners — biotechs and CROs who want to shape an AI-native protocol authoring platform from the ground up. Request a walkthrough and we will be in touch within twenty-four hours.
No sales pitch. A thirty-minute walkthrough with the founder.
We will be in touch within twenty-four hours to schedule your walkthrough. Watch your inbox for confirmation.