Clinion EDC

Clinion EDC is an Electronic Data Capture (EDC) system that utilizes artificial intelligence to facilitate Clinical Trials across Phases I–IV. The system is designed to increase data accuracy, reduce manual task requirements in study configuration and Data Management, and optimize clinical trial operations through automation and standardized workflows.

The platform integrates EDC functions with machine learning to support study configuration, real-time data review, and automated reporting. It allows for Protocol Amendments without interrupting study operations. Clinion EDC operates within an integrated environment that connects modules such as RTSM (Randomization and Trial Supply Management), ePRO (Electronic Patient-Reported Outcome), CTMS (Clinical Trial Management System), eConsent, and eSource.

Clinion is utilized by Clinical Research Organizations (CROs) for biotechnology and pharmaceutical studies to maintain regulatory compliance and centralized data visibility.

Key Capabilities:

AI-Enabled Data Management

Clinion includes AI-supported functions for Discrepancy Detection, data review, and Natural Language Processing (NLP) for reporting. These features are intended to reduce manual oversight and support shorter database lock timelines.

Study Build and Configuration

The platform employs Global Libraries with CDASH (Clinical Data Acquisition Standards Harmonization) templates to facilitate study setup without custom coding. Configuration is performed using reusable forms and customizable Edit Checks.

Real-Time Protocol Amendments

Technical updates to forms or fields can be applied to Active Studies without downtime. Version Control is used to maintain Data Integrity during system changes.

Agentic AI Data Review

An AI agent analyzes the protocol and CRF (Case Report Form) to detect discrepancies and generate queries. Data Managers review these queries before submission to the EDC, which is intended to reduce manual review requirements.

Automated Reporting

Users can generate reports via natural language prompts. The system supports Audit Trails, automated scheduling, and integration through APIs (Application Programming Interface).

CDISC Compliance Support

AI-assisted mapping facilitates CDASH alignment and variable standardization within a single workflow.

Agentic AI Assistant

An embedded AI assistant provides context-aware guidance across the platform to help users navigate workflows and reduce reliance on external support.

Platform Integration