EDC by Clinion

Clinion EDC is an electronic data capture tool for collecting, validating, and managing clinical trial data across Phase I to IV studies. Developed by Clinion, it is used by sponsors, CROs, and biotech companies, and builds AI functions into study setup, data review, CDISC mapping, reporting, and user support.

The tool is part of Clinion's wider suite of clinical trial modules and shares a single data environment with them, giving users one place to view study data across modules.

Study setup

• Codeless study configuration from a standardized global library of prebuilt, CDASH-compliant templates specific to each therapeutic area.
• Forms can be duplicated, and edit checks, skip logic, and other configurations can be customized individually or bulk-edited.
• The vendor reports an average go-live of 2–4 weeks, a study build in under two weeks, and up to a 50% reduction in operational build costs.

AI data review and query management

• Data managers can build custom datasets from natural-language prompts and flag data discrepancies directly within the EDC.
• Queries or corrections can be issued in bulk across all affected subjects in a single action, without relying on biostatistics teams.
• AI-powered edit checks identify data errors in real time.
• The vendor reports 40–50% faster time to database lock, 40–50% lower total data management costs, and up to 30% fewer manual errors.

Mid-study changes

• Visits, pages, and fields can be added, edited, or deleted in live studies without vendor assistance and without study downtime.
• Automatic version control preserves existing data; form locks are released when forms are updated.
• Reports always draw on the latest CRF version, removing manual reconciliation.
• The vendor reports roughly 40% savings in time and cost for protocol amendments.

Reporting

• AI Report Generator creates custom reports from natural-language prompts, without programming.
• Supports scheduled notifications to stakeholders, audit trails with version history, and data export to third-party tools via secure APIs.
• The vendor reports 80–90% faster report generation and a 75–85% reduction in reporting costs compared with manual methods.

CDASH mapping

• Users select a study page and send its variables to an AI engine, which returns annotated CDASH mapping suggestions.
• Suggestions can be reviewed, accepted, customized, checked against CDASH libraries, or replaced with the user's own annotations in a single workflow.
• The vendor reports around 40% savings in coding effort.

Other AI functions

• CliniBot: an in-platform conversational assistant trained on the Clinion EDC protocol and user manuals. It guides users through tasks, explains CRF fields and product features, and gives contextual help across modules.
• AI support for remote source data verification and medical coding.

Integrations

• Integrates with Clinion's RTSM, ePRO, eConsent, eSource, eProtocol, CTMS, eTMF, and CSR automation modules.
• Third-party data exchange via secure APIs.

Adoption

• The vendor reports use in more than 655 clinical trials, more than 300,000 subjects across 20+ countries, and more than 100 customers, including 100+ biotech studies and 150+ FDA studies.

Clinion states that its AI functions follow Responsible AI principles covering accountability, transparency, privacy and security, reliability and safety, and fairness.