Preclinical Development
SRI Biosciences is the only full-service contract research organization based on the West Coast. We work with large and small pharmaceutical and biotechnology clients, including global pharmaceutical companies and start-up biotechnology ventures. We provide services that meet worldwide standards and regulatory requirements for investigational new drug (IND) applications, including services that fully comply with the U.S. Food and Drug Administration’s Good Laboratory Practice (GLP) regulations.
We also serve the nonclinical development needs of the National Institutes for Health (NIH)—holding almost every NIH preclinical services contract—as well as supporting the nonclinical development of countermeasures for the Biomedical Advanced Research and Development Authority (BARDA), Defense Threat Reduction Agency (DTRA) and other government agencies.
Program Overview
We offer:
- Discovery ADMET and in vitro metabolism
- Drug metabolism and pharmacokinetics
- Toxicology and safety
- Safety pharmacology
- Genetic toxicology
- Developmental and reproductive toxicology
- Clinical laboratory analysis for preclinical studies
For biotech and pharmaceutical clients that need specialized expertise in the discovery phase, SRI Biosciences provides discovery services for target research initiatives or as an ongoing development resource.
Other key development services include:
- Custom drug synthesis
- Discovery ADMET and in vitro metabolism
- Analytical chemistry and quality control
- Formulation design and development
- Manufacturing of preclinical and clinical trial materials
- Preclinical Development Plan (PDP) preparation and regulatory services
- Phase 1 clinical trial services and strategic development
Featured Projects
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SRI is conducting preclinical development of treatments for diseases such as tuberculosis, West Nile virus, hepatitis, and biodefense pathogens and toxins.
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For the National Institute of Mental Health (NIMH), SRI performs preclinical safety and pharmacokinetics studies for brain imaging agents and drugs to treat mental illnesses.
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A new oral version of a known chelating agent can defend against mass radiation exposure in a terrorist attack.