OSOD has maintained a long and successful history of ocular drug development through its collaboration with CROs in preclinical toxicology, ocular DM/PK, and efficacy studies.
Selecting the Right CRO
- The type and complexity of a study, its place within the development plan as well as cost and timing are all factors that influence the selection of a CRO
Determining the Scope
- Small scale, investigative preclinical studies may not require GLP compliance or may involve the use of an animal model not widely available. In contrast large and complex studies, pivotal in supporting clinical testing applications may benefit from a large full-service laboratory.
Dynamic Service Scaling
- OSOD has assisted clients conducting work at a number to CROs, both large and small. The scope of these services may range from limited such as review of protocols or data, to extensive participation, with full integration of our technical teams and state-of-the-art instrumentation with the CRO facility and team.
Species Relevance
- Our technical teams are experienced and understand species-related ocular differences as well as the logistical factors with study execution that must be considered to obtain high-quality data collection, which we ensure where ever we work.
Regulatory Compliance
- Compliance with regulatory agencies e.g., USDA, and FDA, as applicable, is our priority, and our Quality Assurance team will be involved from the start of a project all the way to submission of our final report.