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.

We have extensive experience in the design, conduct, and interpretation of early phase first-in-human and proof of concept studies, providing the full suite of clinical pharmacology studies, all elements of a regulatory package programme, and translational early efficacy indication solutions in a range of study types including: 

  • Absorption, Metabolism, Excretion, (AME)
  • Bioavailability
  • Bioequivalence
  • 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

ICON’s early clinical services deliver full visibility and control to meet the requirements of increasingly complex clinical trial requirements. Our dedicated early phase specialists will 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. 

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

Increasing complexity of trials

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Delivery of reliable safety and efficacy data faster

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Finding the right clinical settings to support complex assessment

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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

In the latest ISR Phase 1 CRO benchmarking survey ICON outperforms other large CROs in 16 of the 17 operational metrics, with a significant lead differential in 11. We received our highest performance ratings on data quality, operational excellence, technology for real-time access to data, and patient/volunteer recruitment. Overall satisfaction with ICON for Phase 1 services has remained at last year’s all-time high and is amongst the very best of the large CROs. These results reflect our commitment to providing the very best early clinical drug development solutions.