SRI International is an independent nonprofit research institute in Menlo Park, California. It describes itself as "an independent nonprofit R&D institute with deep roots in Silicon Valley"[S1] and states that it was "founded in 1946 as Stanford Research Institute, and independent since 1970."[S1] Its life science arm, SRI Biosciences, offers contract nonclinical services alongside its own research programs, and states that it has more than 200 research and technical staff of whom 40 percent hold doctorates.[S2] This profile covers the nonclinical services a US sponsor would contract, and is explicit about where each compliance statement was found.
Nonclinical services relevant to US drug developers
DMPK, ADME, and bioanalysis
The institute states that it "offers comprehensive drug metabolism and pharmacokinetic (DMPK) services to meet your needs"[S4] and that its "PK studies that meet all U.S. and European IND submission requirements."[S4] Listed work spans discovery ADMET screening, metabolic stability, CYP450 inhibition, plasma protein binding, membrane permeability using PAMPA, Caco-2 and MDCK systems, reaction phenotyping, single and multiple dose pharmacokinetics, bioequivalence and comprehensive ADME with mass balance.[S4] Bioanalytical method development and validation covers small molecules and biologics using LC-MS/MS, GC-MS, HPLC, ELISA and qPCR, with pharmacokinetic and pharmacodynamic analysis.[S4] An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed.
Toxicology and safety pharmacology
The institute states that it "offers mammalian toxicology testing services, in all major species, that follow either routine or customized study designs,"[S4] covering all major routes except inhalation. Listed study types include acute, subchronic and chronic toxicity, dose range finding and maximum tolerated dose, lifetime carcinogenicity, developmental and reproductive toxicology under ICH S5(R3), and genetic toxicology including the Ames test, micronucleus assay and pigA assay.[S4] Safety pharmacology is aligned to the ICH guidelines, which the brochure describes as outlining "recommendations for evaluating the potential for adverse pharmacodynamic and pathophysiological effects on vital functions,"[S4] covering the ICH S7A core and supplemental batteries and ICH S7B cardiovascular safety.[S4] Clinical and anatomic pathology, including necropsy, organ weights and microscopic pathology, is provided within toxicology studies.[S4] Testing of genetically engineered products and medical devices including combination 510(k) products is also offered.[S3]
Formulation and cGMP clinical manufacturing
A distinguishing capability is that the institute can carry a program from formulation into clinical supply. It states that it "offers a full suite of pharmaceutical product capabilities from drug formulation to manufacturing of final drug product under current Good Manufacturing Practices (cGMP) regulations,"[S6] covering preformulation characterization, ICH stability studies, sterile fill and finish and clinical trial material manufacturing for oral, parenteral and topical routes.[S6] The clean room is described as "operated and maintained according to ISO 14644-2 standards."[S6] The brochure cites more than 30 years of formulation experience, more than 225 products advanced into clinical trials and approximately 25 reaching market.[S6]
Research areas and platforms
Alongside the service lines, SRI Biosciences lists discovery stage work in neurological and neurodegenerative disorder models, radiation biology and models, sleep and circadian rhythm studies, toxin models, viral models and anti-infective agents.[S3] It also develops its own diagnostic platforms, including a radiation biodosimeter described as "a low-cost, field-portable triage device that can rapidly assess a person's exposure to ionizing radiation," a qualitative anthrax cartridge test and the Sentinel Nucleic Acid Analysis System.[S9] These are the institute's own development programs rather than contract services; the boundary between the two should be established at the outset of any engagement.
Quality, compliance, and animal welfare (as stated by the institute)
GLP. A current web page states that "SRI's Clinical Analysis Laboratory is fully compliant with FDA Good Laboratory Practice (GLP) regulations."[S5] The company names FDA Good Laboratory Practice regulations in its GLP statement.[S5] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.[R2] Note that this statement is specific to the Clinical Analysis Laboratory rather than presented as an institute-wide status.
Accreditation and licensing, and where these statements appear. The institute states that it "has been accredited by AAALAC since 1974, is licensed by the USDA, holds an OLAW assurance,"[S4] together with "Select Agent Clearance, radioisotope use licenses and DEA Schedule I-V Controlled Substances licenses."[S4] This passage was found in a brochure PDF dated November 2024 that is linked from the current services page, and not on any current web page checked, including the homepage, the about page, the compliance page and the biosciences pages. That matters for a sponsor doing diligence: the claims are the institute's own and carry the date of that document, so their current status should be confirmed directly. No IACUC or 3Rs statement was found in the pages or brochures reviewed, and no CLIA statement was found even though the institute operates a Clinical Analysis Laboratory. AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6]
Recent organizational changes
Two announcements in August 2026 change the institute's footprint. On August 4 it announced that its Clinical Trial Unit in Plymouth, Michigan had been acquired by CTI Clinical Trial and Consulting Services, now operating as CTI Clinical Research Center Michigan, alongside a research partnership between the two organizations.[S7] On August 6 it announced that it will relocate its Silicon Valley headquarters to its PARC campus in Palo Alto, consolidating teams including biosciences.[S8] No completion date was published, and the about page and site footer still show the Menlo Park address.[S1] Sponsors planning multi-year programs should confirm which site will hold their study.
Institute facts
Name
SRI International; the life science arm is SRI Biosciences[S1][S2]
Headquarters
333 Ravenswood Ave, Menlo Park, CA 94025, United States; a move to the PARC campus in Palo Alto was announced in August 2026[S1][S8]
Founded
1946 as Stanford Research Institute; independent since 1970[S1]
Ownership
Independent nonprofit research institute; no parent company and no stock listing[S1]
Staff
About 1,500 researchers and professional staff across the institute; more than 200 research and technical staff in SRI Biosciences, 40 percent with doctorates[S1][S2]
DMPK and ADME, toxicology, ICH S7 safety pharmacology, genetic toxicology, DART, bioanalysis, pathology, formulation and cGMP clinical manufacturing[S4][S6]
Toxicology scope
All major species; all major routes except inhalation[S4]
GLP
The Clinical Analysis Laboratory is stated to be fully compliant with FDA GLP regulations (current web page)[S5]
AAALAC, USDA, OLAW
AAALAC accredited since 1974, USDA licensed, OLAW assurance held. Stated in a brochure PDF dated November 2024, not on the current web pages checked[S4]
Other licenses
Select Agent Clearance; radioisotope use licenses; DEA Schedule I-V controlled substances licenses[S4]
Track record (institute statements)
More than 200 biomedical products moved into clinical trials; more than 225 formulated products into trials with about 25 reaching market[S2][S6]
Recent changes
Clinical Trial Unit in Plymouth, MI divested to CTI in August 2026; Silicon Valley headquarters relocation announced August 2026[S7][S8]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
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