Southern Research is a research organization in Birmingham, Alabama that offers contract research services for drug development. Its about page describes the organization as "a leading contract research organization dedicated to solving complex scientific challenges and translating innovative ideas into practical, life-changing solutions,"[S1] and its history page states that it "has been a leader in scientific discovery and innovation since 1941."[S2] The organization also describes a strategic partnership with the University of Alabama at Birmingham.[S12] This profile summarizes the services, stated compliance information, and company facts most relevant to US sponsors.
Nonclinical services relevant to US drug developers
Infectious disease research and FDA Animal Rule studies
Southern Research describes "secure, compliant BSL-3 facilities to handle select agents and emerging infectious threats"[S4] and lists FDA Animal Rule studies, vaccine efficacy and immunogenicity testing at BSL-2 and BSL-3, and GCLP-compliant clinical trial sample analysis among its infectious disease services.[S4] Pathogens named on that page include influenza, COVID-19, monkeypox, chikungunya, flaviviruses including dengue and Zika, highly pathogenic avian influenza, RSV, HIV, herpes simplex virus, SARS-CoV-1 and SARS-CoV-2, vaccinia, yellow fever, human metapneumovirus (described as under development), and prion diseases.[S4] The page also states "experience handling Tier One Select Agents (e.g., MPOX)."[S4] The FDA Animal Rule is the pathway under 21 CFR 314.610 and 601.91 by which FDA may rely on adequate and well-controlled animal efficacy studies when human efficacy trials are not ethical or feasible; it applies to specific products and does not remove the need for human safety data.[S14]
In vivo toxicology and pharmacology
Toxicology and pharmacology are presented together as one service.[S3] Listed study types are dose range finding (DRF) studies, maximum tolerated dose (MTD) studies, acute and chronic toxicology, and IND-enabling studies, and the page states "over 20 years of GLP toxicology experience."[S3] Species listed are non-human primates (cynomolgus macaque, African green monkey, rhesus macaque), canine, rat, mouse, ferret, rabbit, and cotton rat.[S3] A separate page describes "higher-order animal models (including non-human primates, canines, and ferrets)."[S10] 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.
ADME-Tox, bioanalysis, and pathology
The ADME-Tox service is described as "advanced, reliable, and rapid ADME and toxicity assessments"[S7] and lists cytotoxicity and mitochondrial toxicity screening, mini-ADME and solubility testing, and high-throughput screening.[S7] Bioanalytical services cover "non-GLP discovery studies and GLP-compliant preclinical (IND-enabling) analyses"[S6] using LC-MS methods together with ELISA, PCR, mass spectrometry, flow cytometry, Meso Scale, and Luminex platforms.[S6] Pathology is offered as "integrated pathology services provide comprehensive anatomic and clinical pathology capabilities, essential for every stage of your preclinical research,"[S8] including necropsy and histological processing, hematology, clinical chemistry, coagulation and urinalysis, and neuropathology work such as non-human primate whole-brain assessment and mouse dorsal root ganglion studies, staffed by board-certified veterinary pathologists.[S8]
Drug modalities and therapeutic areas
The drug modalities page describes support for viral vectors used in gene therapy and vaccines, antibody modalities including antibody-drug conjugates (ADCs) and antibody-dependent cellular cytotoxicity (ADCC), mRNA and lipid nanoparticles, and peptides and radiopharmaceuticals, organized as proof-of-concept development, IND-enabling studies, and clinical trial readiness.[S9] The services overview lists infectious disease research, oncology, and emerging and rare disease initiatives as the named areas.[S11] Oncology resources reference xenograft mouse models.[S11]
Quality, compliance, and animal welfare (as stated by the company)
GLP. Several pages state GLP capability: the biocontainment page is headed "GLP-Compliant Facility,"[S5] the toxicology page cites "over 20 years of GLP toxicology experience,"[S3] and the bioanalytical page distinguishes non-GLP discovery work from "GLP-compliant preclinical (IND-enabling) analyses."[S6] 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.[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]
Accreditation and animal welfare. The animal studies page refers to "accredited lab facilities" and "experienced veterinary and animal care staff ensuring high-quality, accredited animal care,"[S10] but the pages reviewed for this profile do not name AAALAC International, do not state a USDA registration, and do not mention an Animal Welfare Assurance with NIH OLAW or an Institutional Animal Care and Use Committee. Sponsors who require these should ask the organization directly which accreditations and registrations it holds, for which sites, and as of what date. 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]
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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