Pricing
Pricing per document, per axis, by page volume and, for scientific review, by reference count. Price shown before validation.
EryonOne
Use cases Clinical trials
Review your clinical trial protocol before submitting it to CTIS
Protocol, synopsis, investigator's brochure: three documents that tell the same trial, and that one late change is enough to misalign. EryonOne checks them against each other and against Annex I of Regulation (EU) No 536/2014, and quotes the passage at stake for every gap.
01 Checks
What EryonOne checks, point by point
Six checks drawn from Regulation (EU) No 536/2014 and your own templates, run on the protocol and the documents that come with it.
What the protocol must contain
Objectives, design, endpoints, population, inclusion and exclusion criteria, statistical methods and choice of sample size, adverse event reporting: Annex I sets what the protocol must contain.
Annex I, section DIdentification and versions
Title, EU trial number, sponsor's protocol code, date and number of the version: identical on the cover page, in the body of the protocol and in its annexes.
Annex I, point 15The synopsis against the protocol
Population, dosing, treatment duration, primary endpoint, sample size: the synopsis must summarise the protocol submitted, not an earlier version.
Annex I, point 24The investigator's brochure against the protocol
The brochure informs the dose and monitoring set in the protocol and carries the Reference Safety Information: EryonOne checks that the protocol refers to the version submitted.
Annex I, section E (points 26 and 30)Documents for participants
The information sheet must be comprehensive, concise, clear, relevant and understandable to a layperson, and say the same as the protocol on risks, inconveniences and data protection.
Regulation 536/2014, Art. 29Your own templates
Protocol template, standard operating procedures, glossary, list of abbreviations: uploaded as requirements, they are checked just like official texts.
Your internal requirements
02 Common gaps
The gaps that cost weeks
A gap between the protocol, its synopsis and the brochure usually triggers a request for information: 12 days at most to reply, and assessment extended by up to 31 days. Without a reply in time, the application lapses.
Version numbers that disagree
The application form, the cover page and the body of the protocol do not quote the same version, or the same date.
Annex I, point 15
A synopsis older than the protocol
The synopsis summarises an earlier version: the sample size, a visit window or an exclusion criterion did not follow the latest change.
Annex I, point 24
A sample size revised without its assumption
The power calculation is revised and the sample size changes in the statistical section, but the assumption behind it stays at the old figure.
Annex I, point 17(u)
An investigator's brochure from another version
The dose justification refers to a version of the brochure other than the one submitted.
Annex I, section E
A protocol submitted as a scanned image
The protocol should, as far as possible, be written in an easily accessible and searchable format: a scanned image cannot be searched.
Annex I, point 16
Annexes cited, but missing
The body of the protocol refers to an annex, a questionnaire or a manual that is not in the submitted dossier.
Dossier consistency
03 How it works
A review, end to end
The protocol, its reference documents, then your call. The example shows a finding as it appears in the report.
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1You upload the protocol and its references
The protocol as a PDF, with the synopsis, the investigator's brochure and, if you have one, your protocol template.
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2You choose the frameworks and axes
Regulation (EU) No 536/2014 with Directive 2001/83/EC for a medicine; Regulation (EU) 2017/745 and the French Public Health Code for a device. The price shows before launch: nothing is charged without your approval.
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3EryonOne returns its findings
Each finding quotes the passage, the document that contradicts it and the requirement at stake, with, where available, a confidence score.
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4You decide
Accept or dismiss each finding: the decision is kept, and this record will serve you at the first substantial modification.
04 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.
05 Limits
What the review does not cover
ICH guidelines, including E6 on good clinical practice, are not covered to date. EryonOne is an assistant: it replaces neither the assessment by authorities and the ethics committee nor the medical and statistical review, and the decision stays with the sponsor.
Frequently asked questions
Your questions about this use case
Can EryonOne review a clinical protocol?
Yes: what Annex I of Regulation (EU) No 536/2014 expects, consistency with the synopsis and the investigator's brochure, format and language. The review does not rely on an ICH framework.
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 medical device clinical investigations covered?
Yes. They fall under Regulation (EU) 2017/745 and, in France, articles L.1125-1 to L.1125-31 of the Public Health Code, which are active in EryonOne. Regulation 536/2014 does not apply and submission does not go through CTIS; the good practice standard is ISO 14155, which you can upload if your licence allows it.
Which clinical trial documents are concerned?
Protocols, synopses, investigator's brochures, participant information sheets, annexes and study materials. For now, review is available on PDF; Word and PowerPoint come next.
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.
How much does a review cost?
The price depends on the number of pages, the axes you choose and, for the scientific axis, the number of references to check. It shows before every launch (pricing), and the first review of a new account is free, for a document of up to 10 pages.
Does my protocol stay confidential?
Yes. Documents are processed in France, in Roubaix, on a SecNumCloud-qualified OVHcloud offer, and are never used to train a model.