Provider profile
Fortrea.
Clinical biometrics
Fortrea describes Phase I–IV study management and documents biometrics work: biostatistics, SAPs, statistical programming with SAS, CDISC outputs, ISS/ISE, DSMB support, PK analysis and clinical data management with EDC and medical coding, offered as full-service, stand-alone or FSP engagements. It lists headquarters in Durham, North Carolina and offices in Canada, India, Poland, Hungary and Australia.
- Website
- fortrea.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
- Biostatistics1
- CDISC data standards3,4
- Clinical data management2
- Data monitoring committee support2
- EDC and database build2,4
- Integrated analyses (ISS/ISE)3
- Medical coding2
- PK analysis and pharmacometrics5,6Stated as pharmacokinetic analysis within clinical pharmacology services
- Statistical analysis plans1,2
- Statistical programming1
- Submission data packages1
Development experience
Development experience
Development stage
- Commercial3,7Stated as Phase IV on the biostatistics page and for study management generally
- Phase 13,7Phase I–IV stated on the biostatistics page and for study management generally
- Phase 23,7Phase I–IV stated on the biostatistics page and for study management generally
- Phase 33,7Phase I–IV stated on the biostatistics page and for study management generally
Locations
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).
Evidence and sources
Evidence and sources
- 1Functional Service Provider - FSP Model Solutions | Fortrea (opens in a new tab)Fortrea · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 2Data Management | Fortrea (opens in a new tab)Fortrea · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 3Fortrea FSP Biostatistics & Statistical Programming Services (opens in a new tab)Fortrea · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 4Global Clinical Data Management FSP | Fortrea Clinical Solutions (opens in a new tab)Fortrea · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 5Clinical Pharmacology Services & Early Phase Drug Development | Fortrea (opens in a new tab)Fortrea · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 6Phase 1 CRO & Early Clinical Development Services | Fortrea (opens in a new tab)Fortrea · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 7Fortrea: Global CRO Advancing Clinical Trials & Drug Development (opens in a new tab)Fortrea · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 8Global Locations | Fortrea Clinical Development (opens in a new tab)Fortrea · 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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