Early Clinical

Global Clinical Research Units

ICON has a large early phase clinical research network with 6 state-of-the-art facilities in North America and Europe. Each clinic is supported by the expertise required to successfully deliver the most complex of healthy volunteer, patient, or hybrid first-in-human and proof-of-concept studies.

Clinical Pharmacology

Across all elements of your program from development plan to clinical study report, we apply integrated medical, scientific and operational excellence that’s dedicated to early phase development essential to reaching decision milestones on-time and with the highest quality insights.

Manufacturing & Pharmacy Services

A seamless, end-to-end approach to formulation development and optimisation for small molecules and biologics. Our comprehensive services cover everything from formulation screening and optimisation to analytical method development, validation, and custom packaging, labelling, and distribution—including specialised support for oncology drugs and carbon-14 labelled products.

Innovative early clinical solutions that will advance your drug development strategy

6
Clinical research units across Europe and the USA
894
Early phase clinical trials over the last 5 years
32,600
Healthy volunteers and patients targeted

ICON is committed to the highest standards of excellence and scientific expertise in early clinical drug development.

Our early clinical services deliver full visibility and control to meet the requirements of increasingly complex clinical trial requirements. A dedicated team of early phase specialists engage with you to develop a trial that is best for your compound. Together we will build a tailored approach that leverages our asset development consulting, clinical pharmacology expertise, extensive research facilities, early phase operational experience, and biometrics capabilities to conduct your trial within both healthy participants and patient populations.

We deliver a range of early clinical studies including:

Asian bridging
Absorption, Distribution, Metabolism, Excretion, (ADME)
Bioavailability
Bioequivalence
Biosimilars
Drug-drug interaction
Food Effect (FE)

Hepatic Impairment
Human Abuse Liability
Lactation studies
Microdose
Multiple Ascending Dose (MAD)
Obesity
Phase 1 First in human

Phase 1b/2a Proof of concept
Renal Impairment
Single Ascending Dose (SAD)
Thorough QT (TQT/) QTc

Asset Development Consulting

In-depth scientific expertise across disciplines.

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Biotech

Helping biotech meet critical milestones

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Clinical Pharmacology

We help design a protocol that works harder and smarter for you.

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Biometrics

Specialised data management, programming, biostatistics and medical writing services

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Manufacturing & Pharmacy Services

A one stop drug development solution that is perfectly suited for early phase trials with shorter timelines.

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Medical Affairs

Unlocking the full potential of early clinical research

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Quantitative Pharmacology and Pharmacometrics

Expert clinical and nonclinical pharmacokinetic, pharmacodynamic, and exposure response data analysis services.

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Bioanalytical and Biomarker Laboratories

Supporting rapid in-house simple analysis with method development, assay validation and specimen analysis.

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Healthy Participant Recruitment

Flexible volunteer recruitment solutions designed to serve the needs of your early phase clinical trial.

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Early Phase Patient Studies

Customised solutions designed to evaluate clinical endpoints and biomarkers within a smaller sample of patients to provide you with reliable proof of concept data.

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Ethnic Bridging Studies

Optimising drug development, reducing duplication, and improving global patient care

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An independent 2026 ISR benchmarking report has ranked ICON as one of the top-performing CROs in Phase 1 clinical trial services. ICON leads the average performance score of all other large CROs in 15 of the 17 operational metrics (equal tie in the remaining 2), with a significant lead differential in 8 of the metrics.

We received our highest performance ratings on 'Therapeutic expertise', 'Operational excellence' , 'Patient/Volunteer recruitment' and 'Easy to work with' operational metrics. Overall satisfaction with ICON for Phase 1 services is at an all-time high, and ICON is the only large CRO listed in the top 3 CROs for customer loyalty for both 2026 and the rolling 3 year average. This consistent, industry-leading performance reflects our strong commitment to excellence in early phase clinical research.

Our dedicated early clinical experts have the experience to address the most demanding early phase drug development challenges including:

Increasing complexity of trials

Delivery of reliable safety and efficacy data faster

Finding the right clinical settings to support complex assessment

Case studies

Explore our case studies showcasing innovative early clinical solutions to advance your drug development strategy. ICON is committed to excellence and scientific expertise in early clinical drug development.

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Early phase challenges for biotechs

This whitepaper explores the growing challenges facing biotech during early phase drug development, and how these can be navigated to ensure the best possible outcomes.

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ICON survey report: Early phase development - understanding key obstacles for biotechs in 2024

ICON conducted a survey of 149 small and medium biotechs to understand the challenges they are currently experiencing in early phase drug development.

Read the survey report