Preclinical Drug Development
SRI Biosciences provides clients with a wide range of services for moving new drug candidates from the laboratory into clinical testing and to the marketplace. The only full-service contract research organization based on the West Coast, SRI works with large and small pharmaceutical and biotechnology clients, including global pharmaceutical companies and start-up biotechnology ventures.
We also serve the nonclinical needs of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), and the National Institute of Aging (NIA).
Scope of Services
To help clients meet their product development objectives, SRI Biosciences offers services ranging from comprehensive drug safety evaluations to scale-up processing of prototype clinical trial materials (CTMs). We provide clients with more than 50 years of expertise and facilities equipped with sophisticated scientific instrumentation. We have AAALAC-accredited facilities and a modern functional manufacturing facility, including an aseptic processing suite.
All of SRI's pharmaceutical development services meet worldwide stringent regulatory requirements. SRI studies are conducted under Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations. For biotech and pharmaceutical clients that need specialized expertise in the discovery phase, SRI provides discovery services for target research initiatives or as an ongoing development resource.
Key development services include
- Analytical chemistry and quality control
- Formulation design and development
- Manufacturing of preclinical and clinical trial materials
- Pharmacokinetics and metabolism
- Discovery ADMET and in vitro metabolism
- Drug substance preparation
- Preclinical Development Plan (PDP) preparation and regulatory services













