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Oracle Clinical

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Oracle Clinical
DeveloperOracle Corporation
Initial release1996
Operating systemMicrosoft Windows (client), Oracle Linux (server)
PlatformOracle Database, Oracle Fusion Middleware
TypeClinical data management system
LicenseProprietary commercial software
WebsiteOfficial website

Oracle Clinical (OC) is a clinical data management system developed by Oracle Corporation for the design of clinical studies, definition of metadata and case report forms (CRFs), data entry and validation, medical coding, and laboratory data management in support of clinical trial operations.[1][2] It is commonly deployed with Oracle's web-based Remote Data Capture (RDC Onsite) for site investigators to enter and review patient data online.[3][4]

Major functions

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OC comprises the following functions:[2][3][5]

  • Study and case report form (CRF) design and metadata definition
  • Central or site-based data entry with edit checks, derivations, and discrepancy management
  • Batch loading and standardized extracts for analysis and reporting
  • Medical thesaurus management for coding adverse events, medical history, and medications
  • Laboratory data management with demographic-aware reference ranges and result flagging

History

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  • Mid-1990s: Oracle Clinical is introduced as part of Oracle’s life-sciences applications portfolio (first documentation references appear in 1996).[4]
  • Adoption in large sponsors (late 1990s–2000s): Deployment at major companies; for example, Boehringer Ingelheim reported selecting Oracle Clinical/RDC as its EDC to integrate with existing clinical databases and scale to most trials.[5]
  • RDC Classic → RDC Onsite (2000s): A web-based interface (RDC Onsite) supersedes the legacy client, enabling browser-based site entry and monitoring documented by sponsors and public research networks.[3]
  • Acquisition era (2009–2012): Oracle expands the health-sciences portfolio with acquisitions of Relsys (Argus Safety, 2009), Phase Forward (2010), and ClearTrial (2012), shaping the broader eClinical suite around OC/RDC.[6][7][8]
  • Cloud transition (2020s): Oracle introduces Clinical One Data Collection as a cloud-native path for trial data capture, positioned alongside or as a successor for on-premises OC/RDC deployments.[9][10]

Adoption and competitors

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OC/RDC are used in academic and government networks, as well as in corporate environments.[2][3] Other products in the same or adjacent space include Medidata Rave, REDCap, and Veeva Vault EDC.[11][12][13][14][15]

See also

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References

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  1. ^ Chow, Shein-Chung (2003). Encyclopedia of Biopharmaceutical Statistics (2nd ed.). Informa Health Care. pp. 397–401. ISBN 0-8247-4261-3. Retrieved 18 October 2025.
  2. ^ a b c Trocky, N. M.; Fontinha, M. (2005). "Quality management tools: facilitating clinical research data integrity by utilizing specialized reports with electronic case report forms". AMIA Annual Symposium Proceedings. PMC 1560767. PMID 16779428. Retrieved 18 October 2025.
  3. ^ a b c d "Getting Started with Remote Data Capture Onsite". National Cancer Institute. Retrieved 18 October 2025.
  4. ^ a b "Oracle Clinical Remote Data Capture Documentation Library". Oracle Help Center. Retrieved 18 October 2025.
  5. ^ a b Collet, Stéphane (2006). "The EDC Decision". Applied Clinical Trials. Retrieved 18 October 2025.
  6. ^ "Oracle to buy drug-safety software maker". Computerworld. 23 March 2009. Retrieved 18 October 2025.
  7. ^ "Oracle buying drug software maker Phase Forward". Reuters. 17 April 2010. Retrieved 18 October 2025.
  8. ^ "Oracle acquires ClearTrial". TechMonitor. 29 March 2012. Retrieved 18 October 2025.
  9. ^ "Oracle Unveils Clinical One Data Collection Cloud Service" (Press release). Oracle. 18 June 2020. Retrieved 18 October 2025.
  10. ^ "Oracle Unveils Clinical One". Applied Clinical Trials. 18 June 2020. Retrieved 18 October 2025.
  11. ^ "Oracle and Phase Forward". Applied Clinical Trials. 28 April 2010. Retrieved 18 October 2025.
  12. ^ "Medidata snags biz from rival Oracle in record Q1". FierceBiotech. 1 May 2012. Retrieved 18 October 2025.
  13. ^ "Global E-Clinical Trial Technologies Industry" (Press release). PR Newswire. 17 July 2013. Retrieved 18 October 2025.
  14. ^ "Directory of Electronic Data Capture (EDC) Systems for Clinical Trials (2025)". CCRPS. 12 June 2025. Retrieved 18 October 2025.
  15. ^ "Top 10 Medidata Rave Alternatives & Competitors in 2025". G2. Retrieved 18 October 2025.
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