Animal Health Safety

The Cloudbyz Animal Health Safety platform is a cloud-native pharmacovigilance and safety solution purpose-built to support pre- and post-approval safety tracking in animal health clinical trials. From managing VeDDRA-coded adverse event reports to maintaining GCP compliant audit trails, the platform supports the complete lifecycle of safety data across species, studies, and global markets.

Designed for use by sponsors and CROs involved in Target Animal Safety Studies (TASS), TAES, and post-market surveillance, Cloudbyz helps ensure regulatory readiness while improving visibility and operational efficiency.

Product Features

Species-Specific AE/SAE Tracking

Track adverse events and serious adverse events using built-in VeDDRA-coded dictionaries to support species-specific accuracy. Custom fields and structured templates allow recording of organ function, behavioral indicators, and other animal health safety metrics across species and breeds.

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Species-Specific AE/SAE Tracking

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Unified Safety Case Management

Capture, review, and process safety cases from clinical to post-authorization phases. Built-in case workflow logic ensures routing, role-based assignments, and automatic case closure triggers for events that meet specified resolution criteria.

GCP-Compliant Audit Trails

Ensure traceability of every safety-related action with automated, version-controlled logs. The platform is preconfigured to align with VICH GCP (GL9) requirements, ensuring audit-readiness across all study phases.

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GCP-Compliant Audit Trails

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Custom Safety Rules & Triggers

Configure protocol-specific alert logic and auto-escalation rules for abnormal findings. This includes rule sets for unblinding, species-specific lab value deviations, or repeated behavioral anomalies.

Integration with Animal Health EDC

Seamlessly receive safety-related data from connected EDCs. The platform ensures continuous data sync and de-duplication, supporting accuracy across decentralized trial environments.

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Integration with Animal Health EDC

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Global Reporting & Submission Readiness

Auto-generate safety narratives, line listings, and regulatory report forms required for FDA CVM, EMA CVMP, or USDA CVB submissions. Includes support for periodic safety update reports (PSURs) and adverse event reconciliation logs.

Owner-Reported Outcomes & Vet Input Forms

Enable easy collection of owner feedback on suspected adverse events via structured digital forms. Veterinary staff can validate and annotate owner entries, ensuring structured and validated input in real time.

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Owner-Reported Outcomes & Vet Input Forms

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Post-Market Surveillance

Monitor safety trends post-approval and link findings to potential product labeling changes.

Mobile-Ready Safety Entry

Support real-time AE/SAE entry from field-based TAES sites with responsive forms. Enables investigators, veterinary nurses, and mobile staff to report safety incidents instantly and securely.