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 drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies Replicate unknown pathological models and Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc. (Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
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