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

Source: https://onco.cc/technologies/clinical-trial-software/  
OnCo record `clinical-trial-software` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-08
- Tags: supporting
- 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

## Sources

- FDA guidance: electronic source data in clinical investigations: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- technologies: [AI trial matching & clinical decision support](https://onco.cc/technologies/ai-trial-matching/), [Contract research organisations (CROs)](https://onco.cc/technologies/contract-research-organisations/), [Decentralised and hybrid clinical trials](https://onco.cc/technologies/decentralised-clinical-trials/)
- companies: [Clario](https://onco.cc/companies/clario/), [IQVIA](https://onco.cc/companies/iqvia/), [Medidata (Dassault Systèmes)](https://onco.cc/companies/medidata/), [Oracle Health (Cerner) & Oracle Life Sciences](https://onco.cc/companies/oracle-health-sciences/), [Veeva Systems](https://onco.cc/companies/veeva-systems/)

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