IIT Research Institute, known as IITRI, is a nonclinical contract research organization in Chicago, Illinois. It describes itself as "a midsize preclinical contract research organization located in Chicago, Illinois"[S1] and states that it "operates as an independent, not-for-profit preclinical contract research organization and research institute."[S2] It was "founded in 1936 as the research arm of the Illinois Institute of Technology (IIT)."[S2] All study functions are run from a single Chicago site.[S1] This profile summarizes the services, facilities, stated compliance information, and institute facts most relevant to US sponsors.
Nonclinical services relevant to US drug developers
Toxicology and carcinogenicity
The company describes itself as "a high-quality provider of preclinical toxicology and drug safety evaluation services in accordance with GLP standards, with over 40 years of experience."[S4] Study types listed include maximum tolerated dose and dose-range finding; acute, subchronic and chronic toxicity; repeated-dose toxicity; reproductive toxicology including juvenile studies; genetic toxicology (the Ames test under OECD Test Guideline 471, mammalian cell mutation under OECD 476, and the in vivo micronucleus assay); and developmental and reproductive toxicology covering fertility, embryo-fetal and pre- and post-natal designs.[S4] Carcinogenicity is offered both as the two-year rodent bioassay and as a six-month study in the rasH2 transgenic mouse, which the company describes as carrying "both the human homolog of the Hras oncogene and the murine Ha-ras oncogene."[S6] Species listed for toxicology are mouse, rat, guinea pig and rabbit among rodents and lagomorphs; canine, minipig and ferret among non-rodents; and marmoset, cynomolgus monkey, rhesus macaque and African green monkey among non-human primates.[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.
Safety pharmacology and inhalation toxicology
Safety pharmacology is offered as a separate service, described as examining "potentially harmful pharmacodynamic effects on physiological functions, particularly targeting the cardiovascular, respiratory, and central nervous systems."[S5] Listed study types are the functional observation battery, neurotoxicity assessment, telemetered cardiovascular measurement of blood pressure, heart rate and ECG, the hERG in vitro assay, and respiratory plethysmography.[S5] Separately, the company offers inhalation toxicology, describing "comprehensive preclinical inhalation toxicology services for development of inhaled drugs, infectious aerosol challenge studies in BSL-2 and BSL-3 containment," with nose-only exposure across mice, rats, rabbits, canines and non-human primates and characterization of the exposure atmosphere.[S16]
Infectious disease and biocontainment
The institute states that it "has over 10,000 square feet of CDC-approved, Biosafety Level 2 and Biosafety Level 3+ laboratory space (BSL-2 and BSL-3+), including BSL-3 enhanced animal biosafety labs (ABSL-3+),"[S7] and that it is "fully registered with the CDC and USDA for possession and use of select agents and toxins."[S7] Its infectious disease model library is described as "an extensive collection of infectious disease animal models with a large library of bacterial and viral pathogens (including CDC select agents)," with "selected models include influenza, COVID-19, Tularemia, plague, and Zika."[S8] Species used for these models are listed as mouse, ferret, guinea pig, cotton rat, rabbit, rat and non-human primate.[S8]
Bioanalysis, pathology, immunology, and device testing
The bioanalytical laboratory is described as "GLP-compliant", without identifying on that page whether the FDA, EPA or OECD regime is meant and "onsite at our single Chicago, IL location for efficient and transport-free coordination of study teams and sample analysis,"[S9] covering HPLC and LC-MS method development and validation, dose formulation analysis, PK and TK analysis, bioavailability, biodistribution and bioequivalence studies, radiolabeled drug studies, ELISA and qPCR.[S9] Histology and histopathology support includes traveling necropsy teams, aseptic tissue collection for molecular assays, standard and special stains, and processing of oversized tissues.[S10] Immunology services listed are anti-drug antibody assays, flow cytometry immunophenotyping, ELISpot, hemagglutination inhibition, neutralizing antibody assays and antibody-dependent cell-mediated cytotoxicity.[S11] Medical device testing covers cytotoxicity, genotoxicity to ISO 10993-3:2014, bioburden analysis and in vitro diagnostic device support.[S12]
Quality, compliance, and animal welfare (as stated by the institute)
GLP. The institute states that it has "conducted GLP compliant studies since the inception of GLP in 1979 and maintain strong relationships with all regulatory agencies,"[S3] and that its quality assurance team members are Registered Quality Assurance Professionals in GLP.[S13] The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.[S3] 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] The animal welfare page names FDA and EPA GLP regulations among the guidelines the institute follows, alongside the Guide for the Care and Use of Laboratory Animals, the PHS Policy and the Animal Welfare Act.[S14]
Accreditation, registration, and licenses. The toxicology page states that "the IITRI vivarium is fully AALAC-accredited, USDA registered, and operates under an Animal Welfare Assurance (#A3475-01) approved by the NIH-OLAW"[S4] (the misspelling of AAALAC is the site's own), and the biocontainment page states that "since 1975, IITRI animal facilities have been fully and continuously accredited by the Association for the AAALAC."[S7] The quality page additionally lists a US Drug Enforcement Administration Schedule I controlled substance license, CDC registration, a radioactive material license, a Department of Defense Top Secret facility security clearance with Biological Select Agents and Toxins coverage, and participation in the HHS Biological Personnel Reliability Program.[S13] 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]
Inspections. The quality page states that the institute's facilities "are routinely inspected by the FDA and EPA," and that inspection results "are available upon the request of our sponsors."[S13] No inspection dates or classifications are published. FDA inspects nonclinical laboratories under its Bioresearch Monitoring program but does not approve or certify laboratories, so an inspection history is not an FDA endorsement.[R6] Sponsors who need to assess inspection outcomes should request the underlying documentation.
Animal welfare. The institute states that its "management and staff are dedicated to following the animal welfare 'Five Freedoms' concept originating in the UK in 1965,"[S14] and lists the Guide for the Care and Use of Laboratory Animals, the PHS Policy, the Animal Welfare Act and its regulations, and the FDA and EPA GLP regulations as the governing documents, with an Institutional Animal Care and Use Committee providing oversight.[S14] The 3Rs terminology is not used on the pages reviewed. This profile does not evaluate the institute's animal care program; the statements above are its own.
10 West 35th Street, Chicago, IL 60616, United States[S16]
Founded
1936, as the research arm of the Illinois Institute of Technology[S2]
Ownership
Independent, not-for-profit contract research organization and research institute[S2]
Sites
A single Chicago campus; all study functions are run there[S1]
Facility size
Stated as a 100,000 square foot Chicago facility on the about, advantage and history pages, and as over 110,000 square feet with 48 animal rooms on the toxicology page[S1][S3][S4]
Biocontainment
Over 10,000 sq ft of BSL-2 and BSL-3+ space including ABSL-3+ animal laboratories; registered with CDC and USDA for select agents and toxins[S7]
Staff
Headcount not published; the institute states that one third of staff hold advanced degrees including PhD, DVM and MS[S3]
GLP
The institute states that it has conducted studies described as GLP since 1979; the statement does not specify the FDA, EPA or OECD regime, so confirm the applicable one study by study[S3][R2]
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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