Scientific and terminological consistency
Flag inconsistencies between objectives, endpoints, population, design, procedures, units and definitions.
Clinical trials ICH GCP
Review of clinical trial documents ICH GCP
EryonOne supports the review of protocols, investigator brochures and study documents in French or English, with a consistency, readability and documentary quality angle.
Protocols and IB
Documentary quality
PDF only for now
French and English
Benefits
What the review checks
Operational readability
Spot ambiguous passages for clinical teams, CROs, medical writers or regulatory affairs.
Documentary traceability
Help check versions, appendices, cross-references, tables and responses to internal or external comments.
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
Limits of the review
EryonOne does not validate ICH GCP compliance nor a protocol. Sponsor, quality, medical, ethics committee, competent authority or investigator decisions remain human.
Frequently asked questions
FAQ
Can EryonOne review a clinical protocol?
Yes. The tool can help review a protocol with a consistency, readability, terminology and documentary quality angle.
Which clinical trial documents are concerned?
Protocols, synopses, investigator brochures, appendices, study materials or related documents, depending on the defined scope.
Does the review guarantee ICH GCP compliance?
No. EryonOne helps identify points of attention, but does not conclude on regulatory or clinical compliance.
Are English documents accepted?
Yes. Documents in French and English can be handled depending on the use case.
Next step
Prepare a clinical protocol review
Indicate the document type, language and expected review level to frame a first processing run.