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EDC

Electronic data capture with integrated ePRO, eConsent, and query management for clinical trials.

Solution by Curebase
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Overview

Curebase EDC is an electronic data capture solution built for clinical trials, designed for use by sites, sponsors, and CROs. It operates as a fully integrated component of the Curebase platform, connecting EDC functionality with ePRO, eConsent, participant recruitment, and engagement tools within a single structured workflow.

The system supports data collection on-site or remotely across devices, including laptops and tablets, and is configured to meet CDISC compliance requirements for data export. It is intended to reduce setup time while maintaining data quality through built-in validation, query management, and audit trail capabilities.

Core Capabilities

  • Create and configure case report forms (CRFs), adverse event and serious adverse event (AE/SAE) logs, and medication logs
  • Integrate EDC data with ePRO and eConsent data collected through the same platform
  • Collect data on-site or remotely, across multiple device types
  • Built-in query management and resolution tools for monitors and site users
  • CDISC-compliant data export with full audit trails
  • Data freeze and lock functionality
  • Real-time dashboards and notifications for principal investigators and study teams

Platform Features

  • All-in-One Integration: EDC is fully integrated with ePRO, eConsent, and participant engagement tools, supporting a unified study workflow
  • Streamlined CRF Entry: Interfaces for case report forms, adverse events, medications, and log forms are designed for ease of use at the site level
  • Data Review Tools: Supports freeze, lock, and query functions built for both monitors and site staff
  • Real-Time Insights: Dashboards and notifications keep study teams and PIs informed throughout the trial
  • Tablet-Ready Design: Optimized for site workflows on both laptops and tablets
  • Configurable Setup: Form builder and configurable workflows allow rapid study configuration without compromising data quality standards

Workflow Steps

  1. Design: Configure CRFs, validation rules, and workflows using an intuitive form builder
  2. Capture: Sites enter data on any device with real-time validation and edit checks applied at the point of entry
  3. Review: Freeze, lock, query, and export CDISC-compliant data supported by full audit trails

Curebase EDC is part of a broader platform that also includes ePRO, eConsent, recruitment, engagement, eCOA Vigilance, and AI tools. An interactive demo is available without requiring sign-up, allowing site and participant perspectives to be explored directly.

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
BiotechCROMedical DevicesPharma
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11