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Veterinary CRO versus Veterinary SMO

The terms veterinary site management organization (Veterinary SMO) and veterinary contract research organization (Veterinary CRO) are often used in the same context. However, their functions may differ just like the SMOs and CROs involved with human clinical research.  One distinction between a veterinary SMO and veterinary CRO is research subject (patient) interaction.  CROs typically are not directly involved with patient interactions, where veterinary SMOs are usually responsible for enrolling subjects and acquiring data.

Veterinary CROs may provide a variety of services for the pharmaceutical industry. Veterinary CROs may have colony animals that are housed on-site and may be used for pK/pD, tolerance, and safety studies.  However, many veterinary CROs don’t have colony animals and serve in the capacity of multi-site clinical trial management for field studies.   The following lists some of the services that veterinary CROs may provide to clients:

• research and development planning
• clinical trial and project management
• target animal clinical studies (GLP and GCP)
• veterinary regulatory support, preparation of master file technical sections, and regulatory submissions
• bioanalytical services, ADME, pharmacokinetics and pharmacodynamics
• stability and microbiology testing
• technical writing

Veterinary SMOs are typically those organizations that support the on-site performance of the field studies.  Veterinary SMOs primarily focus on managing veterinary research visits, data collection, and site specific protocol compliance.  A veterinary SMO is usually not involved in the pre-clinical or bioanalytical aspects of the R&D process or any regulatory submissions.  Rather, veterinary SMOs are primarily focused on implementing and completing site specific duties and responsibilities for pilot and pivotal studies.

Veterinary site management organizations may work with more than one veterinary clinical trial site.  At the end of the study, the veterinary SMO is responsible for ensuring appropriate archiving of veterinary source and study related documents.