EDC platform review

Oracle Clinical One review

Clinical One Data Collection is Oracle's cloud EDC on the Oracle Clinical One Platform, where randomisation and trial supply (RTSM) are configured and run in the same system. It is aimed at sponsors and CROs running clinical trials and collects data from eCRFs, EHRs, labs, wearables and patient apps.

Facts checked: November 2026 · Rank 12 of 18 · How we rank

Official website Compare all 18 tools

Our score: 6.3/10
Best for: Sponsor trials needing randomisation and drug supply alongside EDC
Pricing: Quote-based ('Contact us' / 'Request a demo')
Vendor: Oracle (Oracle Life Sciences), Austin, Texas, USA

Unique feature

EDC and randomisation in one platform

In Oracle's documented study flow, the study designer creates forms, visits, treatment arms, the randomisation design, kit types and the dispensation schedule in Clinical One, and site users then enter data and dispense kits in the same cloud service.

Fit

Who Oracle Clinical One suits

Best for

Sponsor and CRO drug trials needing integrated randomisation and supply
Studies that pull EHR data into the eCRF (Oracle Clinical Connector)
Trials with site users working in Japanese or Simplified Chinese

Less suited to

Small studies that need published or free pricing
Teams wanting inferential statistics inside the data capture tool
Projects that require confirmed offline mobile data entry

Features

Key features

What the vendor documents publicly, checked against its own pages. “Not stated” means we could not confirm it, not that it is missing.

✓ Yes◐ Partly+ Add-on– No? Not stated

?Vendor builds your database
✓Build forms yourselfSponsor study designers build forms, visits and rules in Testing mode
✓Audit trailSubject Data report shows who changed data, when and why
✓Electronic signaturesPrincipal investigators sign data at subject level
✓Edit checks at data entryPredefined validation rules and custom JavaScript rules can raise queries
✓Queries and source data verificationSponsor query management; study-level and targeted SDV strategies
✓RandomisationRandomisation and supplies (Clinical One RTSM) on the same platform
◐ePRO and participant self-entryVendor lists patient apps and eCOA as data sources; native ePRO not stated
?eConsent
?Offline mobile data collection
◐Forms in several languagesInterface in English, Japanese, Simplified Chinese; form translation not stated
✓CDISC export (ODM / SDTM)ODM-XML extracts conforming to the CDISC ODM-XML standard
✓Built-in reports and dashboardsStandard reports, data extracts and Oracle Clinical One Analytics
?Built-in statistical analysis
?Numbered tables, figures and listings
✓APIClinical One REST APIs for study data and services
?Free or open-source option

Verdict

Strengths and limitations

Strengths

Randomisation, supplies and EDC configured in one platform
CDISC ODM-XML extracts and documented REST APIs
Vendor states AI-enabled EHR-to-EDC transfer and E2B(R3) safety reporting

Limitations

No published pricing
No user reviews found on TrustRadius listing
eConsent and offline mobile capture not stated

Details

Pricing, hosting and regulation

Pricing

Quote-based ('Contact us' / 'Request a demo'). Published prices: not published. Pricing source.

Hosting and security

Hosting regions: not stated. Vendor-hosted on Oracle Cloud Infrastructure (OCI); specific data centre locations not named. No self-hosting option stated.

Certifications: ISO/IEC 27001 and ISO/IEC 27018: vendor states annual third-party audits (Oracle Life Sciences), ISO 9001:2015 for quality management system (vendor), SOC 2 Type 2 attestation reports (hosting provider, OCI), HDS assessment for French health data (hosting provider, OCI).

Regulatory support

Vendor says its solutions 'support regulatory compliance'; its GxP advisory covers 21 CFR Part 11 and Annex 11, with validation accountability resting with the customer.. Whatever the software offers, your own procedures, validation and training are still needed for a regulated study.

Scale and set-up

Aimed at sponsors and CROs; no study size or site limits stated.. Self-build by sponsor/CRO roles in Testing mode, then verification and Production. Vendor brief claims builds 'in weeks instead of months' and mid-study changes deployed in minutes..

Alternatives

Sources (checked November 2026)