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Veterinary CRO, Business Development, Regulatory and SMO Services for the Pharmaceutical Industry
Woods Consulting, LLC – Veterinary CRO Services
13410 N. 82nd Street
Scottsdale, Arizona 85260
Provided to Clients only
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 Contract Research Organization
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
- pre-clinical 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 Site Management Organization
Veterinary SMOs are typically those organizations that support the on-site performance of the field studies. Unlike CROs, SMOs focus on veterinary patient 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, they 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 site, but are often focused on a single site. At the end of the study, the veterinary SMO is responsible for ensuring appropriate archiving of veterinary source and study related documents.