Early Clinical

Early phase development services that will enable informed decision making for your drug development programme.

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 volunteers 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
  • Microdose
  • Multiple Ascending Dose (MAD)
  • Phase 1 First in human
  • Phase 1b/2a Proof of concept
  • Renal Impairment
  • Single Ascending Dose (SAD)
  • Thorough QT (TQT/) QTc

Accelerated Pharmaceutical Solutions

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

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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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Clinical Research Units

Network of ICON-owned clinics with the ability to deliver the most complex of healthy volunteer, patient, or hybrid first-in-human and proof-of-concept studies.

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Biometrics

Specialised data management, programming, biostatistics and medical writing services

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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 Volunteer 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 2025 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 other large CROs in all 17 operational metrics, with a significant lead differential in 14. 

We outperformed the phase 1 industry average for all metrics, receiving our highest performance ratings on 'Easy to work with', 'Meeting overall project timelines' and 'Technology for real-time access to data'. Overall satisfaction with ICON for Phase 1 services has remained at last year’s all-time high and is the highest of all large CROs. This consistent, industry-leading performance reflects our strong commitment to excellence in early phase clinical research. Read more in the press release. 

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

Increasing complexity of trials

Early phase trial challenges

Delivery of reliable safety and efficacy data faster

Clinical research data validation

Finding the right clinical settings to support complex assessment

Trial site selection criteria

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.

Read the whitepaper

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