Clinical Trial Management System

Purpose-built for animal health clinical trials across species, sites, and study phases
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Clinical Trial Management System

Animal health studies—from Target Animal Safety Studies (TASS) and Target Animal Effectiveness Studies (TAES) to pilot and pivotal field trials—require operational agility, regulatory compliance, and species-specific workflows. Cloudbyz CTMS offers a unified, cloud-native platform designed specifically to manage the complexities of animal health clinical research.

Product Features

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Study Planning & Design

Create animal health specific study plans with prebuilt templates tailored for pilot, pivotal, TASS, and TAES studies. Configure workflows to reflect species, indication, and regulatory pathway—ensuring alignment with CVM, CVB, or EMA-CVMP requirements.

Multi-Species Site Management

Onboard and qualify animal health sites using digital feasibility tools, automated Site Qualification Visit (SQV) workflows, and animal health GCP checklists. Assign tasks by site, species, and protocol using built-in DOA logs.

Protocol & Visit Management

Define and track multi-species visit schedules, treatment windows, and protocol-specific activities. Configure dosing cohorts (e.g., 1x, 3x, 5x) for target species and receive real-time alerts for dosing variances or visit delays.

Subject (Animal) Lifecycle Tracking

Manage individual animals or herds from screening through follow-up. Track inclusion/exclusion criteria, consent from owners, and species-specific metrics—such as weight, temperature, lesion score, or behavioral responses.

Randomization & Stratification

Support randomization and stratified allocation by species, breed, weight, or study arm. Integrated with RTSM to handle IP shipment, expiry, and emergency unblinding for animal health studies.

Monitoring

Digitally manage MVRs tailored for animal health sites. Track site compliance, enrollment status, and data quality—automated alerts highlight underperformance, missed assessments, or deviation risks.

Serious Adverse Event (SAE) Tracking

Log AEs/SAEs using VeDDRA-coded species terminology. Capture investigator notes, attach diagnostics, and track resolution timelines. All activity is logged with GCP-compliant audit trails for regulatory reporting.

Milestone & Activity Management

Plan, assign, and monitor trial milestones—from site initiation to database lock. Built-in workflows guide sponsors and CROs across animal health trial timelines, with milestone status dashboards across geographies and species.

Budget & Financial Tracking

Track investigator and veterinarian payments, visit-based reimbursements, and owner stipends. Align financial tracking with actual enrollment and dosing data across multiple sites and species.

Site & Investigator Portal

Enable seamless collaboration between sponsors, CROs, veterinary PIs, and field investigators. Share visit schedules, protocol amendments, safety alerts, and data queries—all within a secure, role-based portal.

Audit Trails & Inspection Readiness

Maintain a fully auditable record of all trial actions, from owner consent to protocol deviations. Version-controlled documents, time-stamped actions, and regulatory folders prepare you for CVM, CVB, or EMA inspections.

Dashboards & Reports

Use configurable dashboards to track enrollment by species, safety signals, site performance, and data completion. Export regulatory-ready reports and operational summaries with a single click.

Why Cloudbyz CTMS for Animal Health?

Built for Multi-Species Trials
Fully Compliant
Unified Oversight
Mobile-Enabled
Secure & Scalable

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