EryonOne Use cases Clinical trials

Review a clinical protocol and its documents

EryonOne reviews protocols, synopses and investigator brochures in French or English: internal consistency, traceability to the references you supply, format and clarity. The regulatory axis relies on Regulation (EU) No 536/2014 and the French Public Health Code; ICH frameworks are not covered to date.

01 Benefits

What the review covers today

Internal consistency of the document

Flag gaps between objectives, endpoints, population, design, procedures, units and definitions, from one section to the next.

Traceability to the references supplied

Link claims to the documents you attach to the project, and flag missing or contradictory supporting material.

Format and clarity

Heading hierarchy, expected sections, cross-references, tables and appendices; wording that is ambiguous for clinical teams, CROs or medical writers.

02 Use cases

Documents and teams concerned

Clinical protocols, synopses, investigator brochures, appendices and study materials.

Sponsors, biotech, medtech, pharma, CRO and clinical operations.

Medical writing, quality, pharmacovigilance and regulatory affairs.

03 Limits

What the review does not cover

EryonOne is an assistant, not a validator. Business responsibility (regulatory, medical, quality, legal) stays with your teams. The report is working material, not an approval.

Frequently asked questions

Your questions about this use case

Can EryonOne review a clinical protocol?
Yes, on internal consistency, traceability to the references supplied, format and language, and on the regulatory axis when you select Regulation (EU) No 536/2014 or the French Public Health Code. The review does not rely on an ICH framework.
Which clinical trial documents are concerned?
Protocols, synopses, investigator brochures, appendices and study materials. For now, review is available on PDF. Word and PowerPoint come next.
Are the ICH frameworks covered?
Not to date. The Clinical Trials Regulation (EU) No 536/2014 and articles L.1125-1 et seq. of the French Public Health Code, for medical device clinical investigations, are active and selectable: see the frameworks covered. ICH is planned, with no committed date.
Are English documents accepted?
Yes. The report comes out in French or English; the reviewed document may also be in Spanish, German, Italian, Portuguese or Dutch.
Next step

Prepare a clinical protocol review

Tell us the document type, the language and the axes you expect. Demo and quote requests go through the contact form.

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Go further

The product

Pricing

Pricing per document, per axis, by page volume and, for scientific review, by reference count. Price shown before validation.

Frameworks

MDR by class, IVDR, ANSM doctrine, Directive 2001/83/EC, French Public Health Code: the exact scope of every active framework, and the ones planned next.

Your requirements

Procedures, charters, claim matrices, licensed standards: the sector-by-sector list of documents to upload as requirements in EryonOne.

What it changes

What AI-assisted review changes for a regulatory affairs team: spot, justify, arbitrate. The decision stays with your team.

Roadmap

What is shipped, in progress and planned in EryonOne: dated releases, upcoming work announced by quarter.

By use case

Pharma and ANSM

Spot the sensitive passages in a health promotional material (claims, benefit/risk balance, consistency with the SmPC) before internal approval.

Leaflet and SmPC

EryonOne helps compare a patient leaflet and an SmPC, both ways, when the documents are provided as main document and reference.

Welcome offer

Your first review is free

Create your EryonOne account and upload your first document: the quote shows “free” and no credits are deducted.

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Offer valid for every new EryonOne account, to be used within 30 days; a reminder is sent 5 days before it expires. No commitment: the reviews that follow show their price before every launch.