CBSET

What CBSET does

CBSET, Inc. is a Lexington, Massachusetts-based preclinical Contract Research Organization (CRO) operating as a not-for-profit since 2006. It provides GLP and non-GLP compliant research services to medical device, pharmaceutical, diagnostic, and biotechnology companies, spanning medical device testing, drug and cell-based therapies evaluation, histopathology and morphometry, auditory safety and efficacy studies, and physician training. Its core technology platform integrates in vivo testing, detailed histopathological analysis, and computational modeling within a single organization, with specialization in cardiovascular (sympathetic denervation, CAD, PAD, drug-coated balloons, thrombectomy), bone and joint health, and oncology therapeutic areas.

CBSET operates a project-based B2B professional services model, engaging directly with enterprise R&D and regulatory teams. Pricing is not publicly disclosed and is structured per study based on complexity, duration, and regulatory requirements. Distribution is global via direct enterprise sales, with a stated emphasis on shortening product lifecycles and time-to-market for novel medical innovations.

In October 2025, Arlington Capital Partners made a majority growth investment to fund capacity expansion and strategic acquisitions. CBSET is currently building a 110,000 square-foot facility in Waltham, MA (former Sanofi-Genzyme site) expected to open Q4 2026, replacing the Lexington headquarters and tripling capacity. The company is positioning the new facility as a gateway service for foreign biotechs entering the US market, exemplified by its partnership with Cilcare. Michael C. John joined as Chief Regulatory and Innovation Officer in January 2026.

Name

CBSET

Legal name

CBSET, Inc.

Website

https://cbset.org

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

101–250 employees

Short description

CBSET is a not-for-profit preclinical CRO offering integrated GLP and non-GLP research services, including medical device testing, drug and cell-based therapies evaluation, and histopathology, to medical device, pharmaceutical, diagnostic, and biotech clients.

Ownership category

akta.pro rank

Product category

Preclinical Contract Research

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (54171), Medical Laboratories (621511)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734), Services-Medical Laboratories (8071)

akta.pro primary industry

Preclinical CROs (Discovery/Pharmacology/DMPK) (HLAGAAAB)

akta.pro secondary industries

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC), Imaging & Cardiac Safety Core Labs (ECOG/EEG/ECG) (HLAGAAAJ)

Keywords

• Preclinical research services
• Contract research organization
• Medical device testing
• Drug safety evaluation
• Histopathology services

Headquarters

HQ city

Lexington

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Preclinical Research Services: Contract research services for medical device, pharmaceutical, diagnostic, and biotech industries including GLP and non-GLP studies, in vivo testing, and regulatory support

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

CBSET is a preclinical Contract Research Organization (CRO) that provides GLP and non-GLP research services to the medical device, pharmaceutical, diagnostic, and biotechnology industries. Its offerings span medical device testing, drug and cell-based therapies evaluation, histopathology and morphometry, auditory safety and efficacy studies, and physician training. CBSET emphasizes an integrated approach combining in vivo testing, histopathological analysis, and computational modeling to advance biomedical science from "benchtop to bedside."

Product overview

CBSET is a preclinical research and development Contract Research Organization (CRO) offering a unified portfolio of integrated services rather than a modular software platform. The core offerings include Medical Device Testing, Drug & Cell-Based Therapies evaluation, Histopathology & Morphometry, Auditory Safety & Efficacy Services, and Physician Training. These services are supported by GLP and non-GLP research capabilities, combining in vivo testing, detailed histopathological analysis, and computational modeling. The company focuses on specific therapeutic areas including cardiovascular conditions (sympathetic denervation, coronary artery disease, peripheral artery disease, drug-coated balloons, thrombectomy/thrombolysis), bone and joint health, and oncology.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Testing Preclinical research and testing services for medical device manufacturers, providing GLP and non-GLP studies to support regulatory submissions.
• Drug & Cell-Based Therapies Preclinical evaluation services for pharmaceutical compounds and cell-based therapeutics, supporting IND-enabling studies and drug development pipelines.
• Histopathology & Morphometry Histopathology and quantitative morphometry services for tissue samples from preclinical studies, providing detailed cellular and tissue-level analysis.
• Auditory Safety & Efficacy Services Specialized preclinical testing for auditory safety and efficacy, including ototoxicity assessment of drugs and medical devices.
• Physician Training Educational and training programs for physicians on novel therapies, devices, and procedural techniques emerging from CBSET's research activities.
• GLP and Non-GLP Research Services Full suite of GLP-compliant and non-GLP preclinical research studies, providing regulated and exploratory research data for clients across multiple industries.

Quantifiable outcome

• Tripling capacity with new Waltham facility

Named customers2 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• CilcarenotableStrategic or Co-development PartnerCilcare, a biotech company, has expanded its US operations through a partnership with CBSET, including clinical trials at Massachusetts General Hospital and threefold capacity growth. CBSET serves as a gateway for Cilcare's expansion into the American market.

Scale indicators4 records

Recent moves2 records

Expansion highlights5 records

Broad incumbents

• Charles River Laboratories: Largest global preclinical CRO with extensive in vivo, safety assessment, and GLP capabilities. Directly competes with CBSET in medical device and pharma preclinical studies but operates at vastly greater scale and global reach.
• WuXi AppTec: Global CRO/CDMO with extensive preclinical safety, toxicology, and bioanalytical capabilities. Provides broader service portfolio at significantly larger scale than CBSET, including US operations via WuXi US AppTec.
• Eurofins Scientific: Large global testing services group with significant central laboratory, bioanalytical, and preclinical testing capabilities through subsidiaries including Eurofins BioPharma Product Testing. Adjacent competitor in laboratory testing services.
• IQVIA: World's largest clinical CRO with adjacent preclinical and laboratory services. Competes for integrated sponsor programs where preclinical-to-clinical continuity matters, especially for large pharma accounts.
• ICON plc: Global CRO with growing preclinical and laboratory services following the PRA Health Sciences merger. Competes for integrated outsourced research programs with both pharma and emerging biotech sponsors.
• Fortrea: Clinical CRO spun out from Labcorp with preclinical and bioanalytical capabilities. Competes with CBSET for early-phase and translational research services from large pharma and biotech sponsors.

Direct peers

• Inotiv: US-based preclinical CRO and research models provider offering in vivo toxicology, GLP studies, and medical device testing. Closest scale and service-mix comparable to CBSET, particularly in device and small-molecule preclinical work.
• Altasciences: Mid-sized preclinical and clinical CRO with strong early-stage drug development services including safety assessment and bioanalysis. Highly comparable in customer base and integrated preclinical offerings.
• NAMSA: Medical device-focused CRO and testing laboratory providing in vivo and in vitro evaluation of devices and combination products. Closest direct peer to CBSET's medical device testing and GLP preclinical service line.
• Toxikon: Preclinical CRO specializing in medical device, pharmaceutical, and combination product GLP toxicology and in vivo testing. Direct peer for medical device preclinical evaluation work.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/CBSETInc

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CBSET