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 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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