01 · Search
Find any case by species
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Clinevo Veterinary Safety
Pharmacovigilance for veterinary medicines
One validated safety database for animal adverse events, from the first report to FDA Form 1932 and VICH E2B(R3) submissions to FDA, EMA and Health Canada.
Runs on the same Clinevo safety database as human pharmacovigilance.
Every report you owe, from one case record
The case is entered once. Each regulatory output is built from it, so what you submit always matches what you recorded.
| Output | For | How Clinevo produces it |
|---|---|---|
| FDA Form 1932 | FDA | Generated from the case record, with the drug, animal species, clinical signs and outcome. |
| VICH E2B(R3) ICSR | FDA, EMA, Health Canada | VICH-compliant XML built from the case and sent through the integrated AS2 gateway. |
| E2B(R2) and E2B(R3) | Partners and licensees | Regulatory XML imported into the database and exported to other systems. |
| Line listings and periodic reports | Internal review and regulators | Generated from the database, with customisable reports for compliance and stakeholders. |
From first report to submission
The same recorded path as every Clinevo safety case, set up for animal adverse events.
- Intake
Reports from the call centre (MICC), web forms and email, plus E2B, EDC and PDF intake.
- Processing
Data entry with validation checks, auto or manual coding, and dynamic workflows.
- Review
Quality and medical review, event assessment, and narratives drafted for the reviewer.
- Reporting
Reporting rules, timeline tracking with alerts, and multi-country submissions in E2B(R2) or (R3).
- Signals
Signal line listings that flag unusual patterns, and periodic reports.
Built around the animal
Species, products and clinical signs are first-class data, so every case can be found, checked and reported.
02 · Data quality
Complete before it is reported
Mandatory fields and validation checks keep every case complete, with follow-ups and outcomes tracked.
03 · Integration
Connected to your systems
APIs for electronic health records and laboratory information systems, and E2B files in and out.
04 · Control
Secure and traceable
Role-based access, encryption in transit and at rest, and an audit trail of every entry, change and access.
One system for patients and animals
Clinevo Veterinary Safety runs on the same safety database as human pharmacovigilance. A company with both portfolios keeps one validated system and one audit trail.
- IQ/OQ/PQ validation included in every engagement
- Built for 21 CFR Part 11, EU Annex 11 and GxP
- 24/7 support from offices in the USA, UK, the Netherlands and India
