MERIT

What MERIT does

MERIT CRO, Inc. is a privately held, Madison, Wisconsin-headquartered clinical trial endpoint services provider founded in 2012, operating across ophthalmology, oncology, respiratory, and cardiology therapeutic areas. The company partners with pharmaceutical sponsors, biotechnology companies, and contract research organizations to deliver centralized imaging and respiratory endpoint assessments for global clinical trials, managing activity across 4,000+ clinical sites in 65 countries and contributing to 300+ FDA/EMEA marketing authorization filings. Its core technology is EXCELSIOR, a cloud-based, FDA 510(k)-cleared Class II medical device (K#220929) originally cleared in 2013 for ophthalmic data management and expanded in 2022 to include CT, MR, and PET radiological image interpretation; the platform supports DICOM ingestion, automated PHI de-identification, BCVA certification across 2,500+ sites, and a configurable spirometry module.

MERIT monetizes through a platform-plus-services model: professional services for endpoint adjudication and reading center work (the primary revenue layer), supplemented by recurring subscription revenue from EXCELSIOR licensing and the Centralized Image Storage program. Pricing is quote-based and tailored per study, distributed through direct enterprise sales to sponsors and channel partnerships with 30+ CROs including 8 of the top 10 globally; the company serves 13 of the top 20 global pharmaceutical companies. Recent corporate actions include the January 2025 acquisition of OSOD, LLC for early-stage drug development capability, formation of MERIT CRO CANADA (Feb 2025) and MERIT CRO AUSTRALIA (Mar 2026) subsidiaries, expansion of the Shanghai office (Sept 2025), and a May 2026 strategic partnership with MTI for respiratory endpoints. Regulatory posture is reinforced by ISO 13485, ISO 27001, HIPAA, 21 CFR Part 11, GDPR, and a clean FDA inspection in March 2026.

Name

MERIT

Legal name

MERIT CRO, Inc.

Website

https://meritcro.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

101–250 employees

Short description

MERIT CRO is a privately held clinical trial endpoint services provider specializing in imaging, spirometry, and reading center services across ophthalmology, oncology, respiratory, and cardiology for global pharma, biotech, and CRO partners.

Ownership category

akta.pro rank

Product category

Clinical Trial Endpoint Services

NAICS

Medical and Diagnostic Laboratories (62151), Medical and Diagnostic Laboratories (6215)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Imaging Core Labs & Clinical Endpoint Adjudication (HLAGAEAH)

akta.pro secondary industry

Site Data Management Support (EDC/Source/SDV Readiness) (HLAGACAL)

Keywords

• Clinical trial services
• Endpoint adjudication
• Imaging core lab
• Spirometry services
• Reading center services

Headquarters

HQ city

Madison

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Endpoint Services: MERIT provides specialized clinical trial endpoint services including imaging endpoint assessments, spirometry overreads, and medical endpoint adjudication for pharmaceutical and biotech sponsors conducting global clinical trials. Services are provided across therapeutic areas including ophthalmology, oncology, respiratory, and cardiology.
2. EXCELSIOR Software Platform: Cloud-based software platform licensed for use in clinical trials. EXCELSIOR is FDA 510(k) cleared as a Class II medical device and is used for image data collection, management, and analysis. Platform supports multiple imaging modalities and provides real-time access for all trial stakeholders.
3. Centralized Image Storage Program: Annual subscription-based service for image collection and centralized storage. Includes project management services, image quality control review, and access to processed images on EXCELSIOR platform.

Go-to-market motion3 records

Distribution channels2 records

Marketing channels8 records

Core offering

MERIT provides specialized clinical trial endpoint services — including imaging endpoint assessments, spirometry overreads, and medical endpoint adjudication — to pharmaceutical, biotech, and CRO clients running global clinical trials. Service delivery is enabled by EXCELSIOR, an FDA 510(k) cleared (K#220929) Class II cloud-based medical-device software platform for managing ophthalmic and radiological clinical trial data across ophthalmology, oncology, respiratory, and cardiology studies.

Product overview

MERIT is a clinical trial endpoint services provider operating on a platform-plus-services model. The core technology is EXCELSIOR, a cloud-based FDA 510(k) cleared software platform (K#220929) for managing ophthalmic and radiological clinical trial data. Around this platform, MERIT offers specialized reading center services across ophthalmology, oncology, and respiratory therapeutic areas, along with BCVA certification services, centralized image storage solutions, and preclinical services. EXCELSIOR serves as the unifying technology enabling single-system data management, real-time access, and workflow integration across all service lines.

Differentiator

Problem solved

Functional benefit

Brands

• EXCELSIOR: Cloud-based imaging software platform for clinical trial endpoint management, FDA 510(k) cleared as a Class II medical device for ophthalmic and radiological indications.

Products and services

• EXCELSIOR Cloud Platform Cloud-based imaging software platform cleared by the FDA as a Class II medical device (K#220929) for managing ophthalmic and radiological clinical trial data. Provides image processing, measurement and analysis tools, DICOM standardization, and supports CT, MR, and PET imaging modalities, with real-time access for all trial stakeholders. Used by pharmaceutical, biotech, and CRO customers running global clinical trials.
• Oncology Imaging Services Centralized imaging endpoint services for oncology clinical trials, including centralized image storage, reader services, and support for 500+ studies across 25+ cancer indications (brain, lung, breast, lymphomas, solid tumors). Supports RECIST 1.1, iRECIST, mRECIST, Lugano, WHO, RANO, Hallek, PCWG3, Cheson, and PERCIST response criteria. Designed for pharmaceutical and biotech sponsors and CROs running oncology trials.
• Ophthalmology Reading Center Services Central review and assessment of ophthalmic images for clinical trials, including BCVA certification, endpoint assessments, and support for various imaging modalities such as SD-OCT, fundus photography, fluorescein angiography, OCT angiography, and microperimetry. Used by sponsors running wet AMD, dry AMD, diabetic retinopathy, geographic atrophy, and gene therapy trials.
• Respiratory/Spirometry Services Centralized spirometry services for respiratory clinical trials including bronchodilator responsiveness testing, serial spirometry, exercise challenge, oscillometry, methacholine challenge, DLCO, FeNO, and 6-minute walk test. Managed via the EXCELSIOR Spirometry Module with real-time global data collection following ATS/ERS guidelines. Serves sponsors running COPD, asthma, IPF, cystic fibrosis, and other respiratory programs.
• BCVA & Visual Function Certification Services Certification services for Best Corrected Visual Acuity (BCVA) and visual function, including full, abbreviated, and express certifications for VA examiners and rooms. Delivered through the EXCELSIOR BCVA Certification System with express certifications completed within 1-2 business days, 24/7 access to certification status, and tracking for 2,500+ sites.
• Centralized Image Storage Solution Annual subscription-based service for prospective image collection with centralized storage and access. Includes image collection, quality checks, site support, and DICOM image file storage with PHI removed, delivered via the EXCELSIOR platform. Designed for early-phase studies requiring centralized image archival.
• MERIT Preclinical Services Preclinical research services including electroretinogram (ERG) and visual evoked potentials (VEP) expertise for toxicity, disease, and therapeutic proof-of-concept studies. Used by sponsors and biotechs developing ophthalmic therapies in preclinical and translational stages.
• Collect & Hold Services Centralized image storage program offered as an annual subscription-based service for early-phase studies requiring prospective image collection, including quality control review and access to processed images on the EXCELSIOR platform.

Quantifiable outcome

• 338,000+ spirometry timepoints graded with average turnaround under 6 hours
• +5 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature5 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• MTI (Medical Testing International)coreStrategic or Co-development Partner · 13 May 2026MERIT announced strategic collaboration with MTI to provide spirometry endpoints. This partnership provides sponsors with a compelling, high-quality alternative in spirometry services, offering innovation in respiratory endpoint provision.
• CRO PartnershipscoreChannel Partner/ Reseller/ DistributorMERIT has partnerships with over 30 CROs including 8 of the top 10 globally. CRO partners integrate MERIT's specialized endpoint services into their clinical trial management offerings for pharmaceutical and biotech sponsors.
• Sponsor CompaniescoreStrategic or Co-development PartnerMERIT has a proven track record providing endpoint expertise to 13 of the top 20 global pharmaceutical companies. Sponsors engage MERIT for specialized endpoint services across ophthalmology, oncology, and respiratory clinical trials.
• Reading Center PartnersminorStrategic or Co-development PartnerMERIT is reading center agnostic and works with external reading center partners in addition to its in-house reading center capabilities, providing flexibility for sponsor requirements.
• Vendor PartnersminorStrategic or Co-development PartnerMERIT collaborates with vendor partners to provide comprehensive solutions to help navigate complex clinical trials, offering integrated service delivery.
• Autolus TherapeuticsminorStrategic or Co-development PartnerMERIT delivered a CAR-T cell manufacturing facility project for Autolus Therapeutics as part of its biomanufacturing services, contributing to sustainable facility development.
• ModernaminorStrategic or Co-development PartnerMERIT completed a clinical biomarker laboratory project for Moderna at Harwell, Oxfordshire, contributing to sustainable biomanufacturing facility development.

Scale indicators11 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• IQVIA: IQVIA is the largest global CRO with extensive technology, real-world evidence, and clinical laboratory capabilities. It is both a competitor to MERIT in endpoint services and a sponsor/partner for some imaging and respiratory endpoint work.
• ICON plc: ICON is a top-5 global CRO offering full-service clinical development including in-house imaging core lab and biomarker capabilities. It competes with MERIT both as a full-service alternative to sponsors and as a channel partner delivering endpoint services alongside its own trials.
• Parexel International: Parexel is a top global CRO with significant oncology, ophthalmology, and rare disease trial expertise. It competes with MERIT for endpoint-heavy sponsor work and is also a current or potential channel partner.
• Medpace: Medpace is a mid-to-large global CRO with strong therapeutic expertise in oncology, ophthalmology, and respiratory. It is comparable to MERIT in therapeutic focus and a competitor for endpoint-heavy Phase II/III trial work.

Direct peers

• Calypse: Calypse (formerly Parexel Informatics, now Calyx) provides imaging management, eClinical, and clinical trial technology solutions to pharma and CROs. It competes directly with MERIT in imaging trial management and reviewer software.
• Clario: Clario is a leading clinical trial endpoint technology provider offering imaging, eCOA, cardiac safety, and respiratory solutions. It directly competes with MERIT in imaging core lab and clinical endpoint services for global pharma and biotech sponsors, and is the result of the merger of ERT and Bioclinica.
• Intrinsic Imaging: Intrinsic Imaging is an imaging core lab providing central radiology and oncology image review for clinical trials. It directly overlaps with MERIT's oncology and radiology imaging endpoint offerings for pharmaceutical and biotech sponsors.
• WorldCare Clinical: WorldCare Clinical is an imaging core lab specializing in independent image review for ophthalmology, oncology, neurology, and cardiology trials. It directly competes with MERIT's reading center services and uses a similar sponsor- and CRO-channel go-to-market.

Regional players

• Tigermed: Tigermed is a leading China-based clinical research organization offering CRO and biostatistics services across APAC. It is a comparable endpoint-services peer in the same geographies where MERIT is expanding (Shanghai and Australia).
• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with a major presence in China providing clinical and preclinical services. It is a regional peer for MERIT in China and competes for global pharma trial flow that MERIT accesses through its Shanghai office.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/build-relation/newsletter-follow?entityUrn=7288625631708291073
• Xx.com/MERITCRO

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles19 records

Subsidiaries3 records

Funding overview

Funding rounds3 records

Investors

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

M&A2 records

Investments

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

Frequently asked questions about MERIT