CBSET, Inc. is a preclinical translational research organization in Lexington, Massachusetts, founded in 2006 and formally named Concord Biomedical Sciences and Emerging Technologies, Inc.[S1][S7] It describes itself as a preclinical translational research institute rather than a conventional contract laboratory.[S2] CBSET states that it houses swine, sheep, calves, rabbits, mice and rats, and operates a purpose-bred swine center.[S3] The species range is the feature that most affects what can be placed here. Alongside mice and rats, CBSET houses swine, sheep, calves and rabbits, and it operates its own purpose-bred swine center.[S3] That makes it relevant to programs where the study must be run in an animal large enough to accept a human-scale implant, catheter or delivery device. The work spans implanted devices, combination drug-device products, and drug and cell therapies, with GLP and non-GLP pathology read out in house.[S4][S5][S6] This profile summarizes the services, facilities, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug developers
Implanted devices and combination products
Device work is described as running from early iteration and mechanistic studies through to large-scale GLP safety assessments, supported by operating suites and several imaging modalities.[S4] Named areas include cardiovascular research, renal and sympathetic denervation, drug-coated balloons, thrombectomy and thrombolysis, hernia repair meshes and fixation devices, bone and joint health, and oncology.[S4] Two further service lines, auditory safety and efficacy testing and physician training, appear by name in the site navigation, but their content pages were not reviewed for this profile, so they are listed here without description.[S9]
Drug and cell-based therapies
For therapeutics, CBSET states that it supports preclinical research from proof of concept through regulatory filing, including IND-enabling GLP studies, and that its scope covers small molecules, biologics and cell-based products.[S5] Named capabilities include pharmacokinetics and biodistribution, delivery paradigms, drug-material interactions and formulation, controlled-release therapeutics, and combination drug-device products.[S5] The emphasis on delivery and on drug-material interaction is consistent with the device side of the business, and is worth raising directly: sponsors developing site-delivered or combination products should ask how the proposed study will assess delivery and drug-material interaction: the question is often how the product behaves at the site where it is placed. 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.
Pathology and morphometry
Histology and histopathology are offered under both GLP and non-GLP, covering slide preparation, primary staining such as Masson trichrome, von Kossa and Movat pentachrome, secondary staining by immunohistochemistry, immunofluorescence and in situ hybridization, tissue biomarker analysis, morphometry and scanning electron microscopy.[S6] The company states that board-certified veterinary pathologists are on staff full time, along with laboratory animal medicine veterinarians.[S4][S6] Resin embedding and morphometry matter for implant work in particular, because implant studies generally call for a different embedding and sectioning workflow from routine paraffin histology, and sponsors should confirm whether the proposed workflow includes resin embedding and morphometry.
Facilities and species
The main site in Lexington, Massachusetts is described as a 40,000 square foot facility housing vivariums, catheterization and imaging laboratories, surgical suites, necropsy, histopathology, scanning electron microscopy and biomechanics.[S3] A second site in Grafton, Massachusetts is a 22,000 square foot swine research center described as AAALAC-accredited and Class A USDA-licensed, supplying purpose-bred swine from a closed colony of purebred Yorkshire pigs.[S3] Housing is stated for swine, sheep, calves, rabbits, mice and rats, with other species on request.[S3] Owning the swine colony rather than buying animals in is relevant to study scheduling and to health status, both of which the company cites as reasons for the arrangement.[S3] A third site in Waltham, Massachusetts is reported to be under construction; the only source located is a company news post reproducing the headline of an external article, so the size and purpose reported there are not treated as confirmed here.[S10]
Quality, compliance, and animal welfare (as stated by the company)
GLP compliance is claimed for the facilities and for named services, including device safety assessments, IND-enabling studies and pathology reporting.[S3][S4][S5][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.[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 distinction matters here because the same site runs both exploratory device iteration work and regulated safety studies, and the company itself presents them as different offerings.[S4]
On animal welfare, CBSET states that its facilities are AAALAC-accredited, USDA-licensed and OLAW-Assured, that animal care follows the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals, and that studies are overseen by an internally governed Institutional Animal Care and Use Committee.[S3] The Grafton swine center is specifically described as Class A USDA licensed.[S3] 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] The site also states an excellent record with FDA and USDA.[S3] That is the company own characterization; inspection outcomes are not published on the pages reviewed, and FDA does not approve or certify testing laboratories.[R6] This profile does not evaluate the company animal care program.
Ownership and organizational status
Two official statements about the status of CBSET do not sit easily together, and both are reproduced here rather than resolved. A press release dated October 1, 2025 states that the private equity firm Arlington Capital Partners completed a majority growth investment in the company, and that it intends to pursue complementary acquisitions to broaden the service offering.[S7] Separately, a services page describes the organization as operating as a non-profit 501(c)(3) institute.[S5] The two company statements use different descriptions of the organizational status, and the reviewed pages do not explain how they relate, so one of these descriptions may be out of date or may refer to a different entity in a restructured group. The About page does not repeat the nonprofit description, and the press release does not address tax status.[S2][S7] Sponsors for whom the distinction matters, for example where institutional status affects contracting or indirect costs, should confirm the current legal entity directly and, if needed, against public records.
Leadership is co-founder led. Peter M. Markham is President and Chief Executive Officer and a co-founder, and Elazer Edelman of the Harvard-MIT Biomedical Engineering Center is Chairman of the Board and a co-founder.[S7][S8] The company added a Chief Regulatory and Innovation Officer in 2026 to build a regulatory consulting business unit, which would place advisory work alongside the laboratory services.[S8] Sponsors should note that a testing laboratory advising on the same submission it supplies data for is a combination worth clarifying in the scope of work.
Company facts
Legal name
Concord Biomedical Sciences and Emerging Technologies, Inc., doing business as CBSET, Inc.[S7]
Headquarters
500 Shire Way, Lexington, MA 02421, United States[S1]
Private. Arlington Capital Partners announced completion of a majority growth investment on October 1, 2025; a services page separately describes the organization as a non-profit 501(c)(3) institute[S5][S7]
Leadership
Peter M. Markham, President and CEO, co-founder; Elazer Edelman, Chairman of the Board, co-founder[S7][S8]
Employees and revenue
Not published
Sites
Lexington, MA (40,000 sq ft); Grafton, MA (22,000 sq ft swine research center); a Waltham, MA facility is reported to be under construction[S3][S10]
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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