Kentucky Clinical Trials Laboratory

What Kentucky Clinical Trials Laboratory does

Kentucky Clinical Trials Laboratory (KCTL) is a privately-held, for-profit clinical research organization founded in 2011 and headquartered in Louisville, Kentucky. The company provides clinical-trial support services — including feasibility assessments, site initiation, specimen collection, and laboratory testing — for biotechnology start-ups, medical device companies, large multinational pharmaceutical firms, and large academic research institutions. Its commercial differentiator is a simplified regulatory pathway that the company states can enable trials to commence in as little as one week, paired with a regional network of partner hospitals, clinics, and physician offices spanning Louisville and Southern Indiana.

KCTL's core technical platform is a clinical diagnostic laboratory running a multi-vendor instrumentation stack that spans coagulation (Stago, Siemens BCS XP, Beckman Coulter TOP), microbiology (bioMerieux VITEK 2 XL, BacT/ALERT 3D, Vidas), immunoassay and chemistry (Beckman Coulter DXC/DXI/Access/Image, Roche Cobas 8000, Siemens Centaur XP, Abbott Architect, BioRad HPLC), point-of-care (Alere i Diagnostics), and hematology/urinalysis (Sysmex XE2100, Beckman Coulter DXH, Siemens CLINITEK). Operations are HIPAA compliant, CLIA registered, and GLP-following, and the most recent FDA Audit returned no deficiencies.

Revenue is generated through negotiated contract research agreements on a quote-based, per-study basis; no public pricing or revenue disclosures are available. The company is privately held with no disclosed institutional investors or funding history, and is led by three directors covering laboratory operations (Jennifer Pitman), business operations (Yenny Lamazares), and legal/regulatory affairs (Bradley Sears). Customer acquisition is relationship-driven, leveraging long-standing partnerships with the Baptist Health network, Hardin Memorial Health, and First Urology to provide site access and specimen supply.

Name

Kentucky Clinical Trials Laboratory

Legal name

Kentucky Clinical Trials Laboratory

Website

https://kentuckyctl.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Kentucky Clinical Trials Laboratory is a privately-held, Louisville-based clinical research organization founded in 2011 that runs clinical trials and diagnostic laboratory services for biotech, pharma, medical device, and academic clients across Kentucky and Southern Indiana.

Ownership category

akta.pro rank

Product category

Clinical Research and Diagnostic Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215)

SIC

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

akta.pro primary industry

Clinical Trial Site Operations & Study Coordination (HLAGACAE)

akta.pro secondary industries

Reference & Esoteric Testing Laboratories (HLAFAMAJ), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB)

Keywords

• Clinical trial services
• Diagnostic laboratory testing
• Specimen collection services
• Contract research organization
• Medical diagnostic research

Headquarters

HQ city

Louisville

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. Clinical Trial Services: KCTL provides clinical trial support services including feasibility assessments, site initiation, specimen collection, and laboratory testing for pharmaceutical, biotechnology, medical device companies, and academic research institutions. Revenue is generated through contract research agreements for clinical studies.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Kentucky Clinical Trials Laboratory conducts pharmaceutical, medical device, and diagnostic clinical trials and provides specimen collection and laboratory testing services for biotechnology start-ups, large multinational pharmaceutical companies, and large academic research institutions. Services span feasibility assessments, site initiation, study execution, and diagnostic testing across coagulation, microbiology, immunoassay/chemistry, point-of-care, hematology, and urinalysis. Trial initiation is supported by a simplified regulatory pathway that allows studies to commence in as little as one week.

Product overview

Kentucky Clinical Trials Laboratory (KCTL) is a clinical research organization offering a unified portfolio of clinical trials services and diagnostic testing capabilities. The core offering centers on conducting clinical trials for medical strategies, treatments, and devices, supported by rapid regulatory pathway initiation. This is complemented by an extensive network of diagnostic testing platforms spanning coagulation, microbiology, immunoassay/chemistry, point-of-care, and hematology/urinalysis services. KCTL also provides specimen collection services. The company operates through partnerships with regional hospitals and clinics, enabling access to diverse patient populations and versatile instrumentation.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trials Services Feasibility assessments, site initiation, and study execution for biotechnology, medical device, and pharmaceutical companies and academic research institutions, supported by a simplified regulatory pathway enabling trials to commence in as little as one week. Includes Investigator Initiated Trials and FDA studies.
• Specimen Collection Services Procurement and collection of specimens and samples for clinical studies, leveraging access to specimens from multiple hospital networks including Baptist Health Louisville, Baptist Health Floyd, Baptist Health LaGrange, Hardin Memorial Health, and First Urology.
• Coagulation Testing Diagnostic coagulation testing using Beckman Coulter TOP, Stago Evolution & Compact, Siemens PFA-100, and Siemens BCS XP analyzers for hemostasis studies in clinical trials.
• Microbiology Testing Microbiology diagnostic services using VITEK 2 XL, BacT/ALERT 3D, and Vidas (bioMerieux), plus Great Basin Portrait Toxigenic C. Difficile Analyzer for clinical study microbiology detection.
• Immunoassay and Chemistry Testing Comprehensive immunoassay and chemistry testing across Beckman Coulter (DXC, DXI, Access, Image), Siemens Centaur XP, Roche Cobas 8000, Roche AVL 9180, Abbott Architect, Advia 1800, BioRad HPLC for Hemoglobin A1C, and Advanced Model 3300 Micro-Osmometer.
• Point of Care Testing Rapid point-of-care diagnostics including Alere i Diagnostics, Biomedical Nova Glucometers, blood gas analyzers, and Clinitek Urinalysis Analyzers for clinical studies.
• Hematology and Urinalysis Testing Hematology and urinalysis testing using Beckman Coulter DXH, Sysmex XE2100, Streck ESR Auto Plus, Dade Behring PFA 100, Siemens CLINITEK systems, Clinitest Advance 500, and Iris Urine Sediment Analyzer.

Quantifiable outcome

• Clinical trials can commence in as little as 1 week
• +1 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Five partnerships are on record, tiered core.

• Baptist Health LouisvillecoreStrategic or Co-development PartnerA 519-bed hospital providing a wide range of healthcare services. KCTL has built relationships with Baptist Health network to access patient populations for clinical trials. The partnership provides access to diverse patient bases and seamless protocol transitions for studies at these facilities.
• Baptist Health Floyd Medical GroupcoreStrategic or Co-development PartnerA county-owned hospital with over 600 physicians and 2,000 associates. Part of the Baptist Health network providing clinical trial site access and specimen collection capabilities for KCTL studies.
• Baptist Health LaGrangecoreStrategic or Co-development PartnerFormerly Tri-County Community Hospital, joined Baptist Health in 1992. Provides additional site capacity for clinical trial recruitment and specimen access.
• Hardin Memorial Health (HMH)coreStrategic or Co-development PartnerAn integrated system serving approximately 400,000 residents in 10 Central Kentucky counties. HMH provides extensive patient access for clinical trials through its network of providers and facilities.
• First UrologycoreStrategic or Co-development PartnerSpecialized urological care provider offering access to patients for urology-related clinical trials. Provides advanced equipment and services for study recruitment.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Medpace: Mid-sized, Cincinnati-based clinical research organization with comprehensive Phase I-IV trial services and a strong central laboratory offering. Highly comparable in therapeutic breadth and U.S. Midwest operational footprint, though materially larger than KCTL.
• IQVIA: Largest global CRO with extensive central lab, site management, and trial delivery capabilities across all therapeutic areas and geographies. Represents the upper bound of competitive pressure KCTL faces from full-service incumbents.
• ICON plc: Global CRO with integrated central laboratory, bioanalytical, and clinical trial services post-PRA Health Sciences merger. Directly comparable lab modality set to KCTL, but at global enterprise scale.
• Labcorp Drug Development (formerly Covance): Global clinical research organization with one of the largest central laboratory networks worldwide and end-to-end Phase I-IV services. Comparable lab modality coverage but operates at vastly greater scale and geographic reach than KCTL.

Direct peers

• Celerion: Specialty clinical research organization focused on early-stage clinical pharmacology and bioequivalence studies with integrated clinical lab capabilities. Closely comparable to KCTL in service mix (trial services + diagnostic lab) and scale.
• QPS Holdings: Mid-sized CRO offering early-phase clinical research with integrated bioanalytical and central lab services across multiple therapeutic areas. Comparable to KCTL in combining clinical trial execution with multi-modality diagnostic testing.

Others

• Boca Biolistics: Specialty provider of biological specimens and clinical research support services. Comparable to KCTL's specimen collection and procurement service line, though less focused on full clinical trial delivery.

Emerging players

• Worldwide Clinical Trials: Mid-sized CRO focused on complex therapeutic areas including neuroscience, cardiometabolic, and rare diseases with central lab capabilities. Comparable in offering combination of trial services and specialized diagnostic expertise.
• Bioanalytical Systems (BASi) / Inotiv: Smaller-scale CRO and bioanalytical laboratory services provider. Comparable to KCTL in offering specialized laboratory testing tied to clinical research support, particularly in early-phase and niche studies.

Regional players

• CTI Clinical Trial and Consulting Services: Cincinnati-based CRO with strong regional Midwest presence, comparable therapeutic breadth, and similar mix of trial site services and specialty capabilities. Operates at modestly larger scale than KCTL in adjacent geography.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/Kentuckyctl
• LinkedInlinkedin.com/company/kentucky-clinical-trials-laboratory

Compliance3 records

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 Kentucky Clinical Trials Laboratory