Cloudbyz Veterinary Vigilance Solution

Modernize post-market surveillance with a unified, species-specific veterinary PV platform.
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Cloudbyz Veterinary Vigilance Solution

The Cloudbyz Animal (Veterinary) Health Pharmacovigilance solution is a cloud-native platform purpose-built for veterinary medicine safety surveillance. Designed for life sciences companies, marketing authorization holders (MAHs), service providers, CROs, and regulatory teams, the platform enables real-time adverse event (AE) collection, processing, and global reporting across companion, livestock, and specialty species.

Whether you're responding to a new safety signal, preparing a PSUR, or reconciling owner-reported cases from distributed geographies, Cloudbyz enables streamlined workflows, compliance with VICH GL24/GL29 and global veterinary regulations (CVM, CVMP, CVB), and cross-functional collaboration from intake to submission.

Product Features

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Multichannel AE/SAE Capture

Collect safety cases from veterinarians, owners, call centers, or field staff. Supports mobile-responsive forms, structured email intake, and contact center integrations to ensure accurate and timely reporting from any source.

VeDDRA-Coded Case Entry

Use built-in VeDDRA coding dictionaries to ensure species-specific terminology for adverse events. Structured data fields enable tracking of symptoms, clinical signs, organ systems, and treatment outcomes with veterinary precision.

Multi-Case Support Beyond AEs

Manage not just AEs but also veterinary product complaints, technical inquiries, and medical questions. Tailored workflows help route cases to the appropriate teams with built-in audit trails and role-based access control.

Veterinary-Aware Smart Forms

Dynamic, rule-driven data entry forms adapt to species, study type, or product category. Auto-fill fields, dropdowns, and pre-configured favorites reduce entry errors and training time.

Owner Feedback & Veterinary Validation

Collect structured safety data directly from pet owners, then enable veterinary professionals to validate and annotate observations, ensuring clean, clinically relevant case narratives.

Advanced Querying & Case Search

Leverage advanced filtering with wildcard support, logic-based search operators, and saved queries to track safety trends or monitor compliance. Quickly locate cases by species, product, geography, or investigator input.

Regulatory-Ready Submissions

Generate compliant safety reports for FDA CVM, EMA, or USDA CVB. Supports HL7-compliant XML formats, VICH-defined schemas, EU Vet XML, and batch AS2-based transmission. Import and reconcile inbound XML cases from Competent Authorities with full traceability.

Signal Detection & Trend Monitoring

Built-in dashboards track safety signals by species, region, product, or treatment phase. Identify abnormal patterns, flag outliers, and trigger investigations with automated signal alerts.

Workflow Automation & Escalation

Automated triage, routing, and alerting ensure critical cases are prioritized. Configure escalation rules for repeated events, abnormal lab values, species-specific thresholds, or label-related issues.

Mobile-Optimized Field Entry

Enable mobile staff, veterinary reps, and remote clinics to enter AE data using secure, responsive digital forms.

Key Benefits

Fully aligned with VICH GL24, GL29, CVM, CVMP, and USDA requirements
HL7 and XML-based regulatory submission support
Support for spontaneous, clinical, and post-market cases across species
Built-in signal detection and trend analysis
Unified data environment with integration to Cloudbyz CTMS, EDC, RTSM
Mobile-ready and field-friendly with minimal training needs

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