Versiti Clinical Trials Services

What Versiti Clinical Trials Services does

Versiti Clinical Trials Services is a 501(c)(3) nonprofit clinical trial services platform operated under the parent entity Versiti, Inc., aggregating five specialty sub-brands: Salus IRB and Pearl IRB (independent review boards), Cenetron (central laboratory in Austin, TX), Pearl Pathways (regulatory and quality consulting), and Quantigen (molecular diagnostics and assay development in Fishers, IN). The platform delivers end-to-end clinical trial support for pharmaceutical, biotechnology, in-vitro diagnostics, and medical device sponsors across Phase I-IV programs, spanning collection kit design and biologistics, study design and site selection, data and project management, protocol writing, and vendor management. The combined organization employs more than 2,000 people across Illinois, Indiana, Michigan, Ohio, Texas, and Wisconsin, and operates two 40,000 sq ft laboratory facilities with HLA Center of Excellence capabilities, biomarker and companion diagnostic assay development, molecular diagnostics, and an integrated IRB submission portal. The organization also supplies blood products for cellular therapy research, including leukopaks and prospective collections, governed by AAHRPP-accredited IRB oversight.

The underlying technology and quality infrastructure is the central differentiator: ISO 15189, CAP, CLIA, AAHRPP, FDA 21 CFR Parts 50 and 56, OHRP 45 CFR Part 46, and ICH E6(R2) accreditations, plus New York State and Pennsylvania Department of Health permits and a CDC permit. Proprietary or specialized components include high-throughput high-resolution HLA typing, sample-to-answer method development, an integrated IVD development platform covering RUO, LDT, and FDA-cleared diagnostic assays, and a GlobeSync online portal for kit ordering alongside IRBManager for IRB submissions.

Versiti Clinical Trials Services generates revenue through professional services contracts (clinical trial management, laboratory and diagnostic testing, regulatory and quality consulting, IRB review) and hardware/product sales (collection kits and biologic materials such as leukopaks). Pricing is quote-based via an RFP submission process rather than standardized tiers, consistent with custom-tailored B2B enterprise engagements. The go-to-market motion combines enterprise field sales with a dedicated business development team, attendance at industry conferences (CAR TCR Summit, SOCRA), LinkedIn Live thought-leadership events, and content marketing through an insights library. Customer segments span pharmaceutical and biotechnology companies, IVD developers, medical device manufacturers, CROs, cell and gene therapy developers, and academic researchers, with no public revenue figures disclosed.

Name

Versiti Clinical Trials Services

Legal name

Versiti, Inc.

Website

https://versiticlinicaltrials.org

Company type

Private

Founded year

1945

Operating status

Operating

Short description

Versiti Clinical Trials Services is a nonprofit 501(c)(3) clinical trial services platform under Versiti, Inc., integrating central laboratory (Cenetron, Quantigen), IRB (Salus, Pearl), and regulatory (Pearl Pathways) services to support pharma, biotech, IVD, device, and cell-and-gene-therapy sponsors across Phase I-IV trials.

Ownership category

akta.pro rank

Product category

Clinical Trial Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Other Scientific and Technical Consulting Services (541690), Medical and Diagnostic Laboratories (6215)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734), Services-Health Services (8000), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

akta.pro secondary industries

Point-of-Care & Decentralized Trial Testing Services (HLAGAEAK), Clinical Trial Site Operations & Study Coordination (HLAGACAE), Gene Therapy Regulatory, Pharmacovigilance & Clinical Operations Services (HLAAACAM), Site Data Management Support (EDC/Source/SDV Readiness) (HLAGACAL), Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA)

Keywords

• Clinical trial services
• Central laboratory services
• Biomarker assay development
• Regulatory consulting services
• IRB review services

Headquarters

HQ city

Milwaukee

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Trial Management Services: End-to-end clinical trial support including collection kit design, assembly and biologistics, study design, site selection, data and project management, protocol management, vendor and supplier management. Services span Phase I-IV clinical research.
2. Laboratory and Diagnostic Services: Central laboratory services including biomarker and assay development, HLA typing, companion diagnostic testing, molecular diagnostics, infectious disease testing, and formulation/CMC services. Revenue generated through testing fees and assay development contracts.
3. Quality and Regulatory Services: Regulatory guidance and global filings, quality strategy services, technical and scientific writing, IRB services. Professional services revenue from consulting and compliance engagements.
4. Blood Products for Research: Leukapheresis products (Leukopaks), prospective blood collections, and non-transfusable starting materials for research. Revenue from biologic material sales to therapeutic developers and researchers.
5. Clinical Supplies and Kit Manufacturing: Cenetron provides collection kit manufacturing, sample storage, biorepository services, specimen handling, site logistics, and clinical supply provision. Revenue from kit sales and supply orders.
6. IRB Review Services: Salus IRB and Pearl IRB provide institutional review board services for human subjects research including single-site, multi-site (sIRB), and international review. Professional services revenue for protocol review and ethical oversight.

Go-to-market motion2 records

Distribution channels6 records

Marketing channels6 records

Core offering

Versiti Clinical Trials Services provides end-to-end clinical trial management, central laboratory services (including HLA typing, biomarker/assay development, companion diagnostics, and molecular diagnostics), quality and regulatory consulting (regulatory guidance, global filings, scientific writing), and blood products (leukopaks, prospective collections, starting materials) for cellular therapy research. The company also operates institutional review board (IRB) services through Salus IRB and Pearl IRB.

Product overview

Versiti Clinical Trial Services is a comprehensive clinical trial services platform combining multiple specialty organizations—Versiti, Cenetron, Pearl Pathways, Pearl IRB, Quantigen, and Salus IRB—into a unified portfolio. The platform provides end-to-end services across clinical trial logistics (collection kits, study design, data management, vendor management), central laboratory services (biomarker development, HLA typing, companion diagnostics, molecular diagnostics, CMC), quality and regulatory services (regulatory guidance, quality strategy, technical writing, IRB services), and specialized blood products for research (leukopaks, prospective collections, starting materials). Services are organized into distinct sub-brands with specific expertise areas including oncology, cell and gene therapy, orphan and rare disease, HLA testing, and in-vitro diagnostics development. The platform supports therapeutic developers, researchers, device manufacturers, and IVD developers through every phase of clinical trials.

Differentiator

Problem solved

Functional benefit

Brands

• Salus IRB: AAHRPP-accredited independent review board with over 35 years of experience specializing in oncology, SBER studies, and sIRB review services.
• Pearl IRB
• Cenetron
• Pearl Pathways
• Quantigen

Products and services

• Clinical Trial Management Services End-to-end clinical trial management services including collection kit design, assembly and biologistics, study design, site selection, data and project management, protocol writing and management, and vendor/supplier management. Services span Phase I-IV clinical research for pharmaceutical and biotechnology sponsors.
• Central Laboratory Services (Cenetron) Central laboratory services for pharmaceutical clinical trials operating from a 40,000 sq ft facility in Austin, Texas. Provides protocol review, technology consultation, laboratory testing, kit manufacturing, sample storage, biorepository services, specimen handling, site logistics, and clinical study data management. Nearly 30 years of operation.
• Quantigen Laboratory Services High-throughput contract research and assay development services from a 40,000 sq ft ISO 15189-accredited facility in Fishers, Indiana. Specializes in sample-to-answer method development and validation across molecular diagnostics, biomarker assay development, and companion diagnostics. Founded in 2008 and joined Versiti in July 2023.
• Salus IRB Services AAHRPP-accredited nonprofit institutional review board providing ethical review of human subjects research, established in 1985. Operates 5 IRB boards meeting five times per week with industry-leading response times, with specialization in oncology, SBER (social, behavioral and educational research) studies, and sIRB review services.
• Pearl IRB Services AAHRPP-accredited central independent review board services balancing the needs of human subjects, sponsors, and sites. Provides ethical review for human subjects research.
• Quality & Regulatory Services (Pearl Pathways) Comprehensive life sciences professional services company providing clinical, regulatory, and quality compliance support for biopharmaceutical, medical device, and diagnostic companies. Services include regulatory guidance and global filings, quality strategy, validation and auditing, technical and scientific writing, and IRB services. Joined Versiti in 2023.
• Blood Products for Research Blood products for cellular and immune therapy research, including leukapheresis products (leukopaks), prospective blood collections, and non-transfusable starting materials (including cord blood). Materials are collected under IRB-governed protocols, with dedicated donor pools available for cellular therapy sponsors.
• HLA Center of Excellence Expertise hub combining high-throughput, high-resolution HLA typing solutions with trial management, logistics, and regulatory support for cell therapies, immune-response therapy development, and clinical development.
• In-Vitro Diagnostics (IVD) Development Integrated clinical, regulatory, and laboratory solutions for IVD development supporting RUO (Research Use Only), LDT (Laboratory Developed Test), and FDA-cleared diagnostic assays from concept to market. Includes companion diagnostic (CDx) assay development and molecular diagnostics.

Quantifiable outcome

• Industry-leading IRB response times with boards meeting five times weekly
• +2 more outcomes

Named customers5 records

Segments6 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

Feature5 records

Scale indicators10 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• ICON plc: Global CRO with central laboratory services (formerly PRA Health's lab) and extensive clinical operations. Comparable to Versiti CTS in central lab and trial management for pharma/biotech sponsors, though at significantly larger scale and broader therapeutic coverage.
• IQVIA: Largest global CRO and clinical-trial services provider, including central laboratory, biomarker, and regulatory consulting capabilities. Overlaps with Versiti CTS across central lab, biomarker assay development, and trial operations but addresses a much broader customer base with deeper resources.
• Labcorp Drug Development (Fortrea): Spun out of Labcorp in 2023 as a standalone CRO with a large global central-laboratory footprint and full Phase I–IV clinical trial services. Directly comparable to Versiti CTS in central lab, biomarker, and clinical trial management, but operates at far greater scale with a public-equity currency.
• Charles River Laboratories: Provides research models, biosafety testing, and central laboratory services for clinical trials, including biomarker and specialty testing. Comparable to Versiti CTS in central lab and biomarker assay work for pharma/biotech sponsors.
• Medpace: Mid-to-large full-service CRO with embedded central laboratory and clinical pharmacology capabilities, focused on small-and-mid-sized biotech. Comparable to Versiti CTS across clinical operations, central lab, and biomarker work for biotech sponsors.

Direct peers

• Advarra: Provider of IRB services (formed by merger of Quorum Review IRB and BioMedical Research Alliance) plus research technology and consulting. Directly comparable to Versiti's Salus IRB and Pearl IRB as an AAHRPP-accredited independent review board serving pharma/biotech/academic sponsors.
• QPS Holdings: Contract research organization with central laboratory, bioanalytical, biomarker, and translational medicine services for clinical trials. Comparable to Versiti CTS central lab and biomarker assay development, with similar mid-sized CRO positioning.
• BRANY: Nonprofit organization providing IRB services, IBC review, and clinical trial compliance support for academic and pharmaceutical sponsors. Comparable to Salus IRB/Pearl IRB within Versiti CTS in human-subjects research protection services.
• Eurofins Central Laboratory: Global central laboratory network providing biomarker, PK/PD, genomic, and specialty testing for clinical trials. Directly comparable to Cenetron and Quantigen central lab services, including assay development and HLA/molecular diagnostics for pharma/biotech sponsors.
• WCG (WIRB-Copernicus Group): Provider of IRB, IBC, biosafety, and clinical-trial technology services to pharma/biotech sponsors and academic institutions. Directly comparable to Versiti CTS IRB services (Salus/Pearl IRB) as an AAHRPP-accredited central IRB competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubelinkedin.com/video/live/urn:li:ugcPost:7266858950677938179

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries5 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 Versiti Clinical Trials Services