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IRT in Veterinary Clinical Trials

Randomization and trial supply management for veterinary clinical studies, compliant with EU GCP and GMP regulations.

Solution by S-Clinica
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Overview

S-Clinica's IRT in Veterinary Clinical Trials module delivers a purpose-built Randomisation and Trial Supply Management (RTSM) solution for animal health clinical studies. Designed to meet the requirements introduced by the new Veterinary Medicines Regulation that came into force in 2022, this offering supports sponsors and research teams managing investigational veterinary medicinal products throughout the full trial lifecycle.

The solution is fully compatible with the latest EU legislation and guidelines covering Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), making it suitable for organisations operating within regulated veterinary research environments across Europe and beyond.

Key Capabilities

  • RTSM functionality specifically applicable to veterinary investigational medical product management
  • Support for both national and multinational animal health studies
  • Scalable design accommodating small pilot studies through to large confirmatory studies in support of a veterinary product
  • Prompt RTSM set-up to minimise time from protocol finalisation to study activation
  • Management of studies with complex trial designs
  • Flexible change management to accommodate protocol amendments and evolving study requirements

Regulatory Alignment

  • Built in response to the Veterinary Medicines Regulation entering into force in 2022
  • Fully compatible with current EU GCP guidelines for veterinary clinical trials
  • Compliant with GMP requirements relevant to investigational veterinary medicinal products

S-Clinica's veterinary RTSM module sits within a broader platform that includes clinical supply forecasting, drug and supplies management, direct-to-patient capabilities, and data transfer and integrations, enabling sponsors to manage the full scope of their veterinary clinical trial operations within a single connected environment.

Meta

Domain
Clinical Trial Management
Subdomain
Randomization & Trial Supply Management
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
GxP