SRI Biosciences’ Translational Development Section offers R&D expertise, capabilities and facilities from our Preclinical Development and Clinical Development programs. This combination offers clients and partners integrated, bench-to-bedside capabilities for their therapeutic and device development programs.
Preclinical Development provides services to meet worldwide standards and regulatory requirements for investigational new drug (IND) applications and that fully comply with the U.S. Food and Drug Administration’s Good Laboratory Practice (GLP) regulations.
Development services include:
- Discovery ADMET and in vitro metabolism
- Drug metabolism and pharmacokinetics
- Toxicology and safety
- Safety pharmacology
- Genetic toxicology
- Developmental and reproductive toxicology
Clinical Analysis: SRI Biosciences' Clinical Analysis Laboratory offers extensive preclinical expertise in clinical chemistry, hematology, coagulation, urinalysis and specialized biomarkers. Our dedication to excellence in science, regulatory compliance and high-quality clinical laboratory data services contribute to a complete positive client experience.
Clinical Development: SRI’s Phase 1 Clinical Trial and Strategic Development Services unit, located at a state-of-the-art facility in Plymouth, Michigan, provides clients with an agile, top-tier development organization with the capacity to carry programs from concept to clinic. Our capabilities and services leverage SRI’s core competencies to provide integrated, comprehensive support and extend product development continuity.