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.

Protocols and investigator brochures Internal consistency PDF for now French and English

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.

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.

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

FAQ

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.

Write to us See the covered frameworks What you can upload See pricing

More about EryonOne

What AI-assisted review changes

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

The frameworks we cover

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.

The requirements you can upload

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

The product roadmap

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