Phase I Clinical Trials CROs in United States

Formerly Covance, Labcorp Drug Development provides comprehensive drug development services from early discovery through post-approval. One of the world's largest CROs with extensive nonclinical and clinical capabilities.

A leading global contract research organization acquired by Thermo Fisher Scientific. PPD provides comprehensive clinical development services including laboratory, data management, and regulatory services.

Global biopharmaceutical services company providing clinical research, regulatory consulting, and market access services. Parexel has supported the development of many blockbuster drugs.

Integrated biopharmaceutical solutions company combining clinical development and commercial capabilities. Syneos offers end-to-end solutions from Phase I through product launch and beyond.

Leading IRB, IACUC, and consulting services provider for clinical and preclinical research, plus site management and performance optimization services.

US-based CRO providing full-service Phase I-IV clinical trial support for small and mid-size pharma and biotech with expertise in CNS, oncology, and infectious disease.

Gainesville, Florida-based dermatology and wound care CRO providing Phase I-IV clinical trials, photoprotection testing, and clinical pharmacology services for topical drug products.

Full-service CRO purpose-built for small and mid-size biotech, combining legacy of CATO Research, SMS Oncology, Pharm-Olam, and Nuventra into an integrated clinical development partner.

Full-service CRO integrating translational sciences, clinical pharmacology, bioanalysis, and regulatory strategy from preclinical through Phase IV development.

Full-service CRO based near FDA headquarters with 25+ years of regulatory and clinical trial expertise including adaptive designs, BE/BA studies, and pharmacovigilance.

Phase I-III oncology CRO providing clinical trial management with deep oncology expertise for small and mid-size pharma and biotech sponsors.

Clinical pharmacology and bioanalytical CRO providing Phase I studies, bioequivalence, and PK/PD studies from a purpose-built 150-bed clinical pharmacology unit in Dilworth, Minnesota.

Miami-based full-service CRO specialising in complex and rare disease clinical trials with deep regulatory expertise for accelerated and breakthrough therapy designations.

Clinical research organization providing Phase I-III clinical trial management, monitoring, and regulatory services with a focus on small-to-mid-size biotech and specialty pharma sponsors.

Full-service mid-size CRO specialising in rare diseases, transplantation, nephrology, and immunology across Phase I-IV trials.

Full-service, technology-enabled oncology-focused CRO serving biotechnology and pharmaceutical companies across all clinical phases from Wilmington, Delaware.

Specialized early clinical research CRO providing Phase I clinical pharmacology, bioanalytical, and ADME services from dedicated clinical units.

Celerion's clinical pharmacology facility in Lincoln, Nebraska, providing early-phase clinical trials, BA/BE studies, and cardiac safety testing with a 200+ bed Phase I unit.

Global full-service CRO founded in 1995 with strong Asia-Pacific and European presence, expanded via acquisition of CROMSOURCE for deeper European clinical operations.

The only global full-service CRO focused exclusively on CNS drug development, with involvement in 22 FDA-approved CNS therapies across 13 indications.

New York-based Phase I CRO operating an 80-bed clinical pharmacology unit for first-in-human, CNS, cardiac safety, and abuse liability studies.

Technology-enabled mid-size clinical CRO offering Phase I-IV development services with particular strength in oncology, rare disease, and CNS therapeutic areas.

Mid-size US CRO providing full-service Phase I-IV clinical trial management with expertise in oncology, rare disease, and CNS across 50+ countries.

Pennsylvania-based dermatology and aesthetics specialty CRO providing Phase I-IV clinical trial management and site services for topical, injectable, and device-based products.

New Jersey-based mid-size CRO and FSP provider offering clinical operations, data management, and regulatory services across 40+ countries.

Specialty CRO focused exclusively on CNS clinical trials, neurocognitive endpoint assessments, and central rater training for Phase I-III neuropsychiatric studies.

Full-service clinical CRO providing Phase I-IV development support with emphasis on bioanalytical services, clinical pharmacology, and PK/PD modeling from their Salt Lake City operations.

US-based clinical-stage CRO arm specialising in endocrinology and cortisol-modulation therapeutics with expertise in Phase I-III metabolic and CNS clinical trials.

Labcorp's early development and Phase 1 clinical unit operating dedicated clinical pharmacology facilities. Provides first-in-human, bioavailability/bioequivalence, and thorough QT studies.

US-based CRO specializing in rare disease and pediatric clinical trials, providing end-to-end trial management with deep expertise in orphan drug development and regulatory strategy.

Global tech-enabled full-service CRO with strength in government-sponsored trials, infectious disease, vaccines, ophthalmology, and rare disease clinical development.

Texas-based Phase I clinical research unit specialising in early-phase, first-in-human, and healthy volunteer studies with integrated bioanalytical capabilities.

Contract research organization spun off from Labcorp in 2023. Provides Phase 1–4 clinical development services, patient access solutions, and regulatory consulting globally.

Clinical trial arm of Frontage Laboratories providing Phase I-III services with integrated bioanalytical capabilities, bridging bioanalytical strength with full clinical execution.

Phase I clinical research unit in New Jersey providing first-in-human, food effect, bioequivalence, and early-phase pharmacokinetic studies for pharmaceutical sponsors.

ICON's dedicated early development division operating clinical pharmacology units in the US and Europe, conducting first-in-human, PK/PD, food effect, and drug interaction studies.

Global clinical research and health data analytics company formed from the merger of IMS Health and Quintiles. Offers end-to-end clinical development, real-world evidence, and technology solutions.

Clinical operations arm of the former inVentiv Health (now Syneos Health) providing Phase I-IV trial management with particular expertise in dermatology and CNS therapeutic areas.

US-Korea bridge CRO providing early-phase clinical and regulatory services tailored for Korean life science companies entering the US FDA pathway.

Cincinnati-based full-service CRO providing Phase I-IV clinical trial management, clinical pharmacology, and regulatory consulting services for pharmaceutical and biotech sponsors worldwide.

Phase I-III CRO and integrated research site network specialising in CNS, pain, obesity, and metabolic disease with wholly-owned clinical units in California.

Oncology CRO founded by oncology thought-leaders specializing in Phase I and II immuno-oncology trials in North America and Europe.

Scientifically-driven, global, full-service clinical CRO providing Phase I-IV clinical development services. Medpace is known for its therapeutic expertise and operational efficiency.

US-India hybrid CRO providing clinical trial management, regulatory affairs, pharmacovigilance, and medical writing with cost-effective offshore delivery from India.

Mid-size CRO acquired by IQVIA providing boutique-level clinical development services with deep therapeutic expertise in oncology, CNS, and rare disease for small-to-mid-size biotech sponsors.

US arm of Australian CRO Nucleus Network, operating early phase clinical trials from their Minneapolis facility. Provides Phase 1 studies with access to diverse patient populations.

World's leading ophthalmology-specialized CRO providing full-service clinical development from Phase I through Phase IV exclusively for ophthalmic therapeutics, devices, and surgical products.

Global CRO acquired by ICON in 2021. Provides full-service clinical development, data management, and strategic consulting across all major therapeutic areas.

Mid-size full-service global CRO offering Phase I-IV clinical trial management with strong coverage across emerging markets in Africa, Latin America, and Eastern Europe.

Clinical research site in Phoenix conducting Phase I-IV clinical trials with particular strength in CNS, pain, and metabolic disease studies with rapid enrollment capabilities.

Specialty CRO focused on oncology and rare disease with 2,000+ professionals, known for biomarker-driven trial design, companion diagnostics, and translational research services.

Full-service global CRO providing clinical development services across all phases with deep expertise in CNS, rare disease, and cardiovascular therapeutic areas and strong site networks.

Multi-site clinical research organization conducting Phase I-IV trials with a network of dedicated research sites across the upper Midwest specializing in diverse therapeutic areas.

Specialty CRO focused on cardiometabolic clinical trials. Operates Phase 1–2 studies for obesity, diabetes, NASH/MASH, and cardiovascular endpoints with proprietary biomarker platforms.

California-based clinical CRO providing Phase I-III trial management, monitoring, and project oversight for emerging biotech and small pharma sponsors.

Global CRO providing bioanalytical, clinical pharmacology, and Phase I-IV clinical trial services. QPS operates CLIA-certified bioanalytical laboratories supporting regulated studies.

Translational pharmaceutics CRO/CDMO uniquely combining formulation development and clinical pharmacology under one roof, accelerating drug development timelines by running formulation and clinical testing simultaneously.

Oklahoma-based early-phase clinical research site specialising in Phase I healthy volunteer studies, PK/PD trials, and bioequivalence studies.

Full-service contract research and consulting organization providing clinical trial management, biostatistics, data management, and regulatory services with particular expertise in rare disease and pediatrics.

Full-service CRO founded on biostatistics and data science excellence, supporting Phase I-IV trials across rare disease, immunology, and ophthalmology from Research Triangle Park.

US-based early phase CRO specializing in cardiac safety (thorough QT/QTc) studies, abuse deterrent formulation, and human abuse liability studies. Operates a 120-bed clinical facility.

Specialty CRO with 20+ years of dermatology, aesthetics, gastroenterology, and inflammation clinical trial expertise across the US, Europe, and Australia.

Integrated biopharmaceutical solutions company combining clinical development and commercial capabilities to accelerate customer success from Phase I through product launch.

California-based mid-size CRO providing full-service Phase I-III clinical trial management with deep expertise in oncology, rare disease, and CNS for emerging biotech.

Mid-size CRO specializing in clinical development for small and emerging biotech companies. Now part of Allucent, offering Phase 1–3 trial management and regulatory consulting.

Full-service oncology-focused CRO with 40+ years managing early-phase oncology studies for the National Cancer Institute and biopharma sponsors.

Fully integrated dermatology-dedicated CRO providing nonclinical through Phase III development services exclusively for skin disease products since 1997.

Mission-driven global CRO (formerly FHI Clinical) with 50+ years of heritage managing complex clinical research in resource-limited settings across Africa, Asia, Latin America, and North America.

Oncology-focused CRO founded on the Mayo Clinic campus offering preclinical-to-clinical oncology development with PDX models, flow cytometry, and Phase I/II trial management.

Integrated clinical research site organization operating 20+ dedicated research sites across the US, providing high-quality Phase I-IV clinical trial execution with rapid patient enrollment.

Innovation CRO purpose-built for medical device and IVD development, delivering integrated regulatory, clinical, and laboratory services across cardiovascular, neurological, and ophthalmic indications.

Mid-size global CRO providing Phase I-IV clinical development services with expertise in CNS, cardiovascular, and metabolic disease therapeutic areas.

Mid-size full-service global CRO offering integrated bioanalytical lab services alongside Phase I-IV clinical trial management with a focus on CNS, cardiovascular, and rare disease.