{{Short description | Clinical data management software by Oracle}} {{Use dmy dates|date=October 2025}}
{{Infobox software | name = Oracle Clinical | logo = Oracle logo.svg | logo_size = 200px | developer = Oracle Corporation | released = 1996 | operating_system = Microsoft Windows (client), Oracle Linux (server) | platform = Oracle Database, Oracle Fusion Middleware | genre = Clinical data management system | license = Proprietary commercial software | website = {{Official website|https://docs.oracle.com/en/industries/health-sciences/oracle-clinical-remote-data-capture/index.html}} }}
'''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.<ref>{{cite book | last = Chow | first = Shein-Chung | title = Encyclopedia of Biopharmaceutical Statistics | edition = 2nd | publisher = Informa Health Care | date = 2003 | pages = 397–401 | url = https://books.google.com/books?id=M8S8WVRUIY0C&pg=PA401 | isbn = 0-8247-4261-3 | access-date = 18 October 2025}}</ref><ref name="trocky">{{cite journal | last1 = Trocky | first1 = N. M. | last2 = Fontinha | first2 = M. | title = Quality management tools: facilitating clinical research data integrity by utilizing specialized reports with electronic case report forms | journal = AMIA Annual Symposium Proceedings | year = 2005 | pmid = 16779428 | pmc = 1560767 | url = https://pmc.ncbi.nlm.nih.gov/articles/PMC1560767/ | access-date = 18 October 2025}}</ref> It is commonly deployed with Oracle's web-based Remote Data Capture (RDC Onsite) for site investigators to enter and review patient data online.<ref name="nci">{{cite web | title = Getting Started with Remote Data Capture Onsite | website = National Cancer Institute | url = https://octrials.nci.nih.gov/rdcadfsrnd/xhelp/rdc/footprint/wwhelp/wwhimpl/common/html/wwhelp.htm#context=footprint&file=getstart.02.01.html | access-date = 18 October 2025 }}</ref><ref name="docs">{{cite web | title = Oracle Clinical Remote Data Capture Documentation Library | website = Oracle Help Center | url = https://docs.oracle.com/en/industries/health-sciences/oracle-clinical-remote-data-capture/index.html | access-date = 18 October 2025}}</ref>
== Major functions == OC comprises the following functions:<ref name="trocky"/><ref name="nci"/><ref name="edc">{{cite web | title = The EDC Decision | last = Collet | first = Stéphane | work = Applied Clinical Trials | date = 2006 | url = https://www.appliedclinicaltrialsonline.com/view/edc-decision | access-date = 18 October 2025 }}</ref> * 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 == * Mid-1990s: Oracle Clinical is introduced as part of Oracle’s life-sciences applications portfolio (first documentation references appear in 1996).<ref name="docs"/> * 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.<ref name="edc"/> * 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.<ref name="nci"/> * 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.<ref>{{cite news | work = Computerworld | title = Oracle to buy drug-safety software maker | date = 23 March 2009 | url = https://www.computerworld.com/article/1561792/oracle-to-buy-drug-safety-software-maker.html | access-date = 18 October 2025}}</ref><ref>{{cite news | work = Reuters | title = Oracle buying drug software maker Phase Forward | date = 17 April 2010 | url = https://www.reuters.com/article/business/healthcare-pharmaceuticals/oracle-buying-drug-software-maker-phase-forward-idUSTRE63F2GQ/ | access-date = 18 October 2025}}</ref><ref>{{cite web | work = TechMonitor | title = Oracle acquires ClearTrial | date = 29 March 2012 | url = https://techmonitor.ai/technology/data/oracle-acquires-cleartrial-300312 | access-date = 18 October 2025}}</ref> * 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.<ref>{{cite press release | publisher = Oracle | title = Oracle Unveils Clinical One Data Collection Cloud Service | date = 18 June 2020 | url = https://www.oracle.com/corporate/pressrelease/clinical-one-data-collection-cloud-service-061820.html | access-date = 18 October 2025}}</ref><ref>{{cite magazine | work = Applied Clinical Trials | title = Oracle Unveils Clinical One | date = 18 June 2020 | url = https://www.appliedclinicaltrialsonline.com/view/oracle-unveils-clinical-one-0 | access-date = 18 October 2025}}</ref>
== Adoption and competitors == OC/RDC are used in academic and government networks, as well as in corporate environments.<ref name="trocky"/><ref name="nci"/> Other products in the same or adjacent space include ''Medidata Rave'', REDCap, and ''Veeva Vault EDC''.<ref>{{cite web | work = Applied Clinical Trials | title = Oracle and Phase Forward | date = 28 April 2010 | url = https://www.appliedclinicaltrialsonline.com/view/oracle-and-phase-forward | access-date = 18 October 2025}}</ref><ref>{{cite web | work = FierceBiotech | title = Medidata snags biz from rival Oracle in record Q1 | date = 1 May 2012 | url = https://www.fiercebiotech.com/r-d/medidata-snags-biz-from-rival-oracle-record-q1 | access-date = 18 October 2025}}</ref><ref>{{cite press release | publisher = PR Newswire | title = Global E-Clinical Trial Technologies Industry | date = 17 July 2013 | url = https://www.prnewswire.com/news-releases/global-e-clinical-trial-technologies-industry-215804121.html | access-date = 18 October 2025}}</ref><ref name="edc25">{{cite web | title = Directory of Electronic Data Capture (EDC) Systems for Clinical Trials (2025) | website = CCRPS | date = 12 June 2025 | url = https://ccrps.org/clinical-research-blog/directory-of-electronic-data-capture-edc-systems-for-clinical-trials | access-date = 18 October 2025 }}</ref><ref name="g25">{{cite web | title = Top 10 Medidata Rave Alternatives & Competitors in 2025 | website = G2 | url = https://www.g2.com/products/medidata-rave/competitors/alternatives | access-date = 18 October 2025 }}</ref>
== See also == * Electronic data capture * Clinical trial management system
== References == {{reflist}}
== External links == * {{Official website|https://docs.oracle.com/en/industries/health-sciences/oracle-clinical-remote-data-capture/index.html}}
Category:Medical software Category:Health informatics Category:Clinical trials
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