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Provider profile

ICON.

Clinical biometrics

ICON is a large CRO that documents biostatistics and statistical programming for Phase 1–4 studies, including SAPs, CDISC SDTM/ADaM, ISS/ISE, eSubmission packages, DMC support, adaptive design, SAS programming and pharmacometrics, plus clinical data management with EDC builds and real-world evidence analytics, offered as full-service, standalone or FSP. Its corporate headquarters is in Dublin, Ireland.

Website
iconplc.com (opens in a new tab)
Sources reviewed
November 3, 2026 · Source pages re-checked within 4 months
First published
November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Services and capabilities

  • Adaptive and Bayesian design3
  • Biostatistics1
  • CDISC data standards1
  • Clinical data management2
  • Data monitoring committee support1
  • EDC and database build2
  • Integrated analyses (ISS/ISE)1
  • PK analysis and pharmacometrics4
  • Real-world evidence analytics1
  • Statistical analysis plans1
  • Statistical programming1
  • Submission data packages1

Platforms and methods

Engagement model

  • Full-service1
  • Functional service provision (FSP)1
  • Standalone functional services1

Development experience

Development experience

Development stage

  • Commercial1Stated as Phase 4 for biostatistics and statistical programming services
  • Phase 11Stated for biostatistics and statistical programming services (Phase 1–4)
  • Phase 21Stated for biostatistics and statistical programming services (Phase 1–4)
  • Phase 31Stated for biostatistics and statistical programming services (Phase 1–4)

Locations

Locations

  • Dublin, Ireland · Headquarters5

Quality and regulatory

Quality and regulatory

No quality framework or accreditation is established from reviewed sources. Ask for current certificates and recent inspection history.

Unknowns and questions to ask

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

  • Named statistician and programming lead for your study, and their recent experience in your indication
  • Current capacity and realistic start date for database build and SAP authoring
  • Which CDISC standard versions and FDA Data Standards Catalog requirements they will deliver against
  • EDC system(s) supported and who holds the licence
  • Assumptions behind the budget: number of TLFs, interim analyses, DMC meetings and data transfers
  • How change orders are triggered and priced

Not established from reviewed sources: therapeutic experience, quality frameworks (vendor-reported).

How to choose a clinical biometrics CRO for a Phase 2 trial

Evidence and sources

Evidence and sources

  1. 1Biostatistics | Clinical & Scientific Operations | ICON plc (opens in a new tab)ICON · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2Clinical Data Management | ICON plc (opens in a new tab)ICON · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3Adaptive clinical trial design software & consulting | ICON plc (opens in a new tab)ICON · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Pharmacokinetics | Early Phase | ICON plc (opens in a new tab)ICON · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5ICON plc | Global Office Locator (opens in a new tab)ICON · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.

Something out of date or wrong? Request a correction. Corrections are reviewed against public sources before publication.

Contact

Contact

Contact the provider directly through its public contact page (opens in a new tab). ArgusBio does not forward inquiries to providers and does not receive referral fees.

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