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Clinical trial software (EDC, eCOA, CTMS, RTSM)

Clinical trial software is the set of systems that collect trial data, randomise patients, and keep every form auditable.

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.

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How it works

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

Latest papers

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Query for this technology: (TITLE:"Clinical trial software" OR ABSTRACT:"Clinical trial software" OR TITLE:"EDC, eCOA, CTMS, RTSM" OR ABSTRACT:"EDC, eCOA, CTMS, RTSM") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Clinical trial software (EDC, eCOA, CTMS, RTSM), not a curated reading list.

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AI & Computation

technologies

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AI trial matching & clinical decision supportContract research organisations (CROs)Decentralised and hybrid clinical trials

companies

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ClarioIQVIAMedidata (Dassault Systèmes)Oracle Health (Cerner) & Oracle Life SciencesVeeva Systems