{"entity":{"id":"clinical-trial-software","kind":"technology","name":"Clinical trial software (EDC, eCOA, CTMS, RTSM)","aka":[],"tldr":"Clinical trial software is the set of systems that collect trial data, randomise patients, and keep every form auditable.","summary":"Electronic data capture and trial platforms from Medidata (Dassault Systèmes; Rave), Veeva (Vault CDMS), Oracle (Clinical One), IQVIA (Orchestrated Clinical Trials), Castor, and Medrio run most oncology trials; eCOA/ePRO vendors (Clario, Signant, YPrime) capture patient-reported outcomes; RTSM handles randomisation and drug supply. Risk-based monitoring, direct EHR-to-EDC data flow, and AI-assisted data cleaning are reducing site burden.","status":"standard-of-care","asOf":"2026-09-08","links":[{"label":"FDA guidance: electronic source data in clinical investigations","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["ai-computation"],"technologies":["decentralised-clinical-trials","ai-trial-matching"],"targets":[],"drugs":[],"companies":["medidata","veeva-systems","iqvia","oracle-health-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"principle":"Validated 21 CFR Part 11 systems with audit trails, edit checks, role-based access, and standards (CDISC CDASH/SDTM) for regulatory submission.","strengths":["Regulatory-grade data integrity","Global scale"],"limitations":["Site burden and duplicate data entry","Vendor fragmentation","Cost for academic trials"]},"route":"/technologies/clinical-trial-software/","neighbours":{"section":[{"id":"ai-computation","kind":"section","name":"AI & Computation","route":"/fronts/ai-computation/"}],"technology":[{"id":"ai-trial-matching","kind":"technology","name":"AI trial matching & clinical decision support","route":"/technologies/ai-trial-matching/"},{"id":"contract-research-organisations","kind":"technology","name":"Contract research organisations (CROs)","route":"/technologies/contract-research-organisations/"},{"id":"decentralised-clinical-trials","kind":"technology","name":"Decentralised and hybrid clinical trials","route":"/technologies/decentralised-clinical-trials/"}],"company":[{"id":"clario","kind":"company","name":"Clario","route":"/companies/clario/"},{"id":"iqvia","kind":"company","name":"IQVIA","route":"/companies/iqvia/"},{"id":"medidata","kind":"company","name":"Medidata (Dassault Systèmes)","route":"/companies/medidata/"},{"id":"oracle-health-sciences","kind":"company","name":"Oracle Health (Cerner) & Oracle Life Sciences","route":"/companies/oracle-health-sciences/"},{"id":"veeva-systems","kind":"company","name":"Veeva Systems","route":"/companies/veeva-systems/"}]}}