CTI Clinical Trial and Consulting Services

What CTI Clinical Trial and Consulting Services does

CTI Clinical Trial and Consulting Services is a privately held, full-service contract research organization (CRO) founded in 1999 in Covington, Kentucky, originally established as the Cincinnati Transplant Institute. The company delivers end-to-end clinical development services to pharmaceutical, biotechnology, and medical device sponsors across Phase I–IV studies, including clinical operations, regulatory affairs, biometrics, pharmacovigilance, quality assurance, real-world evidence, and a 30-bed Phase I–IV Clinical Research Center in Norwood, Ohio with on-site pharmacy and laboratory. It also operates a global laboratory network providing bioanalytical, biorepository, and safety testing services, with facilities in Cincinnati (opened 2021) and Bilbao, Spain (ribbon cutting 2023), the latter having received College of American Pathologists (CAP) accreditation for its biorepository. CTI specializes in 13 therapeutic areas, with more than 75% of active studies in rare or orphan diseases and approximately 50% involving regenerative medicine, cell, and gene therapies.

The company generates revenue through project-based CRO contracts (fixed-fee or time-and-materials) negotiated directly with sponsors, supported by a global workforce in more than 60 countries, a 250+ active sponsor base, and a 95% repeat business rate. It has contributed to more than 200 drug and device approvals through the FDA, EMA, and other agencies across more than 10,000 projects since founding. Distribution is exclusively direct-to-sponsor with no channel partners; go-to-market combines enterprise field sales, conference participation (ASCO, ATC, World Vaccine Congress, Cell & Gene Meeting on the Med), thought leadership content including the "Moving Medicine Forward" podcast, and active social channels. Recent strategic actions include the acquisitions of Clinart MENA (2020) and Dynakin (2021), the planned 2026 CEO succession that elevated Jonathan Koch to CEO and Brian Lawrence to CFO & President with founder Tim Schroeder moving to Executive Chairman, and the 2026 expansion of Medical Affairs and Regulatory leadership.

Name

CTI Clinical Trial and Consulting Services

Legal name

CTI Clinical Trial and Consulting Services

Website

https://ctifacts.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

CTI Clinical Trial and Consulting Services is a privately held, full-service CRO founded in 1999 that delivers Phase I–IV clinical research, regulatory, laboratory, and real-world evidence services to 250+ pharmaceutical, biotechnology, and medical device sponsors globally, with deep specialization in rare/orphan diseases and regenerative medicine.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI), Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Clinical research services
• Contract research organization
• Clinical trial management
• Regulatory affairs services
• Biopharmaceutical consulting

Headquarters

HQ city

Covington

HQ country

United States

HQ region

North America

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Research Organization (CRO) Services: CTI generates revenue as a full-service CRO providing contract research services to pharmaceutical, biotechnology, and medical device companies across all phases of clinical development (Phase I-IV). Services include clinical operations, regulatory affairs, laboratory services, real-world evidence, and site-based clinical research. Revenue is generated through project-based contracts with biopharma sponsors, typically structured as fixed-fee or time-and-materials arrangements for defined clinical development programs.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

CTI is a global, privately held, full-service contract research organization (CRO) that delivers end-to-end clinical trial and consulting services for pharmaceutical, biotechnology, and medical device sponsors. The company integrates CRO operations, a dedicated Clinical Research Center (Phase I-IV), and global laboratory services to support drug development across all therapeutic areas and clinical phases.

Product overview

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical research organization (CRO) that provides integrated research services across the entire drug development lifecycle. The company operates its own Clinical Research Center (CRC) facility for Phase I-IV studies, complemented by Global Laboratory Services (bioanalytical, biorepository, safety testing), Clinical Services (feasibility, monitoring, project management, pharmacovigilance, biometrics, QA), Regulatory Development (strategic services, model-informed development), and Real World Evidence/Late Phase services. CTI specializes in 13 therapeutic areas including rare disease, regenerative medicine/gene therapy, transplantation, oncology, and neurology/sleep research. The company also produces the Moving Medicine Forward podcast for industry education.

Differentiator

Problem solved

Functional benefit

Products and services

• CTI Clinical Research Center (CRC)

Quantifiable outcome

• 95% business repeat rate demonstrating high sponsor satisfaction
• +3 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• DynakincoreStrategic or Co-development Partner · 14 July 2021CTI acquired European-based company Dynakin in July 2021. This acquisition expanded CTI's European presence and laboratory capabilities. Details about strategic implications and specifics of the acquisition were not disclosed.

Scale indicators11 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Premier Research: Premier Research is a privately held specialty CRO focused on rare disease, oncology, and pediatric trials; comparable to CTI in therapeutic specialization and customer mix of small-to-mid biotech sponsors.
• Medpace: Medpace is a mid-to-large full-service CRO with a similar operating model of focused sponsor attention, in-house functional capabilities, and strong therapeutic specialization — the most directly comparable peer to CTI in scale and strategy.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized, scientifically focused CRO emphasizing complex and specialty trials across rare disease and CNS — closely mirroring CTI's therapeutic-area depth and project-based service model.

Emerging players

• Pro-ficiency: Pro-ficiency provides clinical trial simulation, protocol optimization, and training tools; thematically adjacent to CTI's Model Informed Development capability and increasingly complementary in trial design workflows.
• Veristat: Veristat is a specialty clinical research and biostatistics organization serving small-to-mid biotech sponsors; overlaps with CTI on biometrics and regulatory strategy for emerging biotech.

Broad incumbents

• Fortrea (formerly Labcorp Drug Development): Fortrea is a large global CRO spun out of Labcorp, offering end-to-end clinical development services; competes with CTI in Phase I-IV execution but with a broader portfolio and larger sponsor relationships.
• Parexel International: Parexel is a global CRO with strong presence in oncology, rare disease, and biopharma services; competes with CTI on mid-to-large sponsor programs across similar therapeutic areas.
• Syneos Health: Syneos Health is a global clinical and commercial services organization; overlaps with CTI on the CRO side while extending further into commercialization, which CTI does not offer.
• ICON plc: ICON is a top-tier global CRO providing full-service clinical development across all phases and therapeutic areas; competes with CTI for enterprise sponsor programs but at materially larger scale.
• IQVIA: IQVIA is the largest global CRO and life sciences technology provider; overlaps with CTI across clinical trial services but operates at much greater scale and with broader technology/data offerings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/cticlinical
• YouTubeyoutube.com/user/CTIClinical
• Facebookfacebook.com/cticlinical
• LinkedInlinkedin.com/company/cti-clinical-trials-and-consulting
• Instagraminstagram.com/cti_facts

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries3 records

Funding overview

Funding rounds

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 CTI Clinical Trial and Consulting Services