Woods Consulting, LLC – Veterinary CRO Services
13410 N. 82nd Street
Scottsdale, Arizona 85260
Provided to Clients only
Veterinary CRO vs 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 in human pharmaceutical research and development. The following provides a some information on the differences between a veterinary CRO and a veterinary SMO.
Veterinary Contract Research Organization
can provide a variety of services for the pharmaceutical industry. Veterinary CROs usually have colony animals that are housed on-site. The following lists many of the services that veterinary CROs may provide to clients:
- research and development planning
- 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
A veterinary CRO may also incorporate SMO services, further described to the right.
Veterinary Site Management Organization
are typically those organizations that support the performance of the field studies, but may also be involved with regulatory submissions. Usaully, a veterinary SMO will not be involved in the pre-clinical or bioanalytical aspects of the R&D process. Rather, they are primarily focused on implementing and completing the pivotal studies required for regulatory submissions.
In this capacity, a veterinary site management organization may have affiliated (contracted) veterinary clinics and hospitals to perform the studies. The veterinary SMO will often have a veterinary trial director, who oversees the veterinary clinical trial from a central location. The veterinary SMO will normally qualify each veterinary clinical trial site, and monitor the study site using veterinary clinical research coordinators (CRCs). The veterinary CRCs will often perform the veterinary trial site initiation visit, and then audit the sites at various stages of the veterinary clinical trial process. At the end of the study, the veterinary SMO will perform a site closeout visit and the veterinary source documents will be stored at the veterinary clinical trial site for potential regulatory auditing.