Synchrony Labs

What Synchrony Labs does

Synchrony Labs is a Contract Research Organization (CRO) specializing in GLP-compliant preclinical testing services for medical device and pharmaceutical companies, headquartered in Durham, North Carolina within the Research Triangle. Founded approximately 40 years ago by cardiology leaders at Duke University Medical School, the company operates a dedicated preclinical facility with 3 operating rooms, 2 cath labs, a surgical suite, and advanced imaging technology including Siemens, Philips, GE, Volcano, and Stryker systems. The company has supported the development, refinement, and testing of devices such as bioabsorbable drug-eluting stents, AAA stent grafts, vascular filters, thrombectomy devices, LAA closure devices, and drug-coated balloons across cardiovascular, orthopedic, neurological, and regenerative medicine applications.

The company generates revenue through project-based professional services contracts covering study design, protocol development, device implantation, performance evaluation, and regulatory report writing for FDA submissions. Pricing is custom and quote-based, with multi-year contracts and flexible scheduling including evening studies. Client acquisition occurs primarily through direct enterprise sales, website consultation requests, and long-tenured industry referrals. Additional service offerings include cadaveric studies and physician training, and strategic partnerships with Structural Heart Imaging and Cardiovascular Masters Consortium extend capabilities into clinical trial support. The firm holds AAALAC International accreditation, GLP compliance under 21 CFR Part 58, and ISO 10993 compliance, supported by a team of board-certified veterinarians, physicians, interventional specialists, and research professionals.

Synchrony Labs operates as a privately held, founder-owned entity with no disclosed external investment, operating from a single U.S. location with a global client footprint claim. The company has served hundreds of clients and completed thousands of studies over its multi-decade history, establishing itself as a specialized preclinical testing partner for medical device innovators navigating the FDA regulatory pathway.

Name

Synchrony Labs

Legal name

Synchrony Labs

Website

https://synchronylabs.com

Company type

Private

Founded year

1984

Operating status

Operating

Headcount range

11–50 employees

Short description

Synchrony Labs is a privately held GLP preclinical CRO in Durham, North Carolina providing regulatory-grade medical device and pharmaceutical testing services, including device implantation, performance evaluation, and imaging analysis, to innovators pursuing FDA submissions.

Ownership category

akta.pro rank

Product category

Preclinical Contract Research Services

NAICS

Scientific Research and Development Services (5417), Testing Laboratories and Services (54138), Medical and Diagnostic Laboratories (6215)

SIC

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

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Clinical Trial Site Operations & Study Coordination (HLAGACAE), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK), Data Management, Reporting & Regulatory Submissions for Central Labs (HLAGAEAL)

Keywords

• Preclinical CRO services
• GLP preclinical research
• Medical device testing
• Large animal model studies
• Biocompatibility testing

Headquarters

HQ city

Durham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Preclinical Contract Research Services: Synchrony Labs operates as a Contract Research Organization (CRO) providing GLP preclinical research services to medical device and pharmaceutical companies. Revenue is generated through project-based professional services including study design, protocol development, device implantation, performance testing, and regulatory report writing. Services are tailored to client needs with flexible scheduling and custom study protocols.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Synchrony Labs is a GLP-compliant Contract Research Organization that designs, executes, and reports preclinical studies for medical device and pharmaceutical companies preparing FDA regulatory submissions. Services span study design and protocol development, device implantation in large animal models, performance and safety evaluation, cadaveric studies, physician training, and rigorous regulatory report writing, all delivered from a Durham, NC facility equipped with advanced imaging and surgical infrastructure.

Product overview

Synchrony Labs is a GLP-compliant preclinical Contract Research Organization (CRO) providing medical device testing services. The company operates a unified platform of preclinical research services centered around its state-of-the-art facility in North Carolina's Research Triangle. Core offerings include GLP preclinical research services for medical device and pharmaceutical industries, comprehensive medical device testing across cardiovascular, orthopedic, neurological, and regenerative medicine applications, and an advanced imaging laboratory equipped with Siemens, Philips, GE, Volcano, and Stryker technology. Additional services include cadaveric studies and physician training programs. The company is affiliated with Structural Heart Imaging (specialized core lab services) and Cardiovascular Masters Consortium (clinical CRO services) for extended trial support.

Differentiator

Problem solved

Functional benefit

Products and services

• GLP Preclinical Research Services End-to-end GLP-compliant preclinical research services for medical device and pharmaceutical companies, covering study design, protocol development, device implantation, performance evaluation, and regulatory report writing under 21 CFR Part 58 for FDA submissions.

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Two partnerships are on record, tiered core.

• Structural Heart ImagingcoreStrategic or Co-development PartnerStructural Heart Imaging delivers specialized core lab services for cardiovascular imaging analysis, extending Synchrony Labs' preclinical capabilities into clinical trial support. This partnership enables transition from preclinical testing to clinical trial imaging services.
• Cardiovascular Masters ConsortiumcoreStrategic or Co-development PartnerCardiovascular Masters Consortium provides clinical CRO services, helping bridge devices from Synchrony Labs' preclinical testing to successful clinical trials. This partnership enables end-to-end development support from preclinical through clinical phases.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Regional players

• ITR Laboratories Canada: ITR Laboratories is a Canada-based preclinical CRO offering medical device, GLP toxicology, and surgical model studies — comparable in service mix to Synchrony Labs but operating primarily in a different geography.

Direct peers

• Toxikon: Toxikon provides preclinical and medical device testing services including ISO 10993 biocompatibility and GLP studies, comparable in scope and regulatory positioning to Synchrony Labs' medical device testing franchise.
• Med Institute: Med Institute provides preclinical and clinical research for medical devices, with deep cardiovascular and structural heart testing capabilities, making it a closely comparable niche CRO to Synchrony Labs.
• NAMSA: NAMSA is a medical device-focused CRO offering preclinical testing, biological safety, and regulatory consulting — overlapping directly with Synchrony's GLP preclinical, ISO 10993 biocompatibility, and FDA submission support services.
• American Preclinical Services (APS): APS is a preclinical CRO offering GLP surgical and medical device studies, catheter-based and imaging research, and large animal model capabilities — a close functional peer to Synchrony's cardiovascular and device testing focus.
• CBSET: CBSET is a preclinical CRO specializing in cardiovascular, neurovascular, and medical device GLP studies using large animal models — directly comparable in therapeutic focus, animal-model expertise, and regulatory positioning to Synchrony Labs.

Broad incumbents

• WuXi AppTec: WuXi AppTec operates a global preclinical and clinical CRO platform including medical device testing services — a broad incumbent offering integrated development support that competes with Synchrony for device and pharma preclinical work.
• Eurofins Scientific: Eurofins operates a global network of testing laboratories including medical device, pharmaceutical, and biocompatibility services — a broad incumbent with overlapping capabilities to Synchrony's ISO 10993 and GLP testing portfolio.
• Charles River Laboratories: Charles River is a global, full-service CRO with a large Safety Assessment / preclinical franchise that includes GLP toxicology and medical device studies — a broad incumbent that competes with Synchrony for preclinical medical device work but at vastly greater scale.
• Fortrea (formerly Labcorp Drug Development): Fortrea is a large clinical and preclinical CRO with medical device and early development capabilities, providing a one-stop-shop alternative that competes for the same enterprise preclinical accounts as Synchrony Labs.

Market position

Strengths5 records

Weaknesses6 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/synchrony_labs
• LinkedInlinkedin.com/company/synchrony-labs-llc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Synchrony Labs