EDC

OpenClinica's Electronic Data Capture (EDC) is a purpose-built eCRF and clinical data management platform designed for sponsors, CROs, and academic research teams. It replaces fragmented, disconnected clinical data tools with a single, unified solution that delivers 21 CFR Part 11 compliance, flexible study design, and dedicated support — without the complexity or cost typically associated with enterprise systems.

Trusted by more than 1,500 sponsors, CROs, and research sites worldwide, OpenClinica EDC is built to serve academic researchers who need compliant templates to speed IRB approval, sponsors and CROs who want to launch studies in weeks without IT bottlenecks, and site coordinators who benefit from an intuitive interface and responsive support to reduce burden and improve data quality.

Key Benefits

• Faster study start-up: Publish studies in hours using templated CRFs, one-click publishing, and onboarding support.
• Cleaner data, fewer queries: Real-time edit checks reduce rework by up to 50%, catching errors at the point of entry.
• Site-friendly design: An intuitive interface that sites and coordinators find easy to adopt and enjoy using.
• Modular by design: Use EDC as a standalone solution or connect it with OpenClinica Recruit, eCOA, Randomization, eConsent, EHR-to-EDC, and Reporting & Analytics as your needs grow — all modules work together seamlessly.
• Regulatory ready from day one: Built-in compliance with 21 CFR Part 11, HIPAA, GCP, and GDPR.
• Integrated medical coding: Classify adverse events and medications directly within the platform using OpenClinica Code, eliminating the need for third-party tools and preventing audit trail gaps.

Platform Features

• Drag-and-drop form builder for rapid eCRF design
• Pre-built, trusted CDASH-aligned CRF templates
• Real-time edit checks and data validations
• Role-based permissions for secure, controlled access
• Audit-ready infrastructure supporting 21 CFR Part 11, HIPAA, and GDPR
• Flexible study designs to accommodate complex protocols
• Full integration with all OpenClinica platform tools
• Transparent, study-based pricing with no hidden fees
• Adverse event classification via OpenClinica Code

How It Works

1. Build with confidence: Design your study using drag-and-drop tools or pre-built CDASH templates, with guidance from the OpenClinica support team throughout the process.
2. Capture clean data: Sites enter data through an intuitive interface with real-time validation and edit checks that catch errors instantly at the source.
3. Monitor and collaborate: Track study progress, manage queries, and perform source data verification (SDV) through centralized oversight tools.
4. Report and submit: Export submission-ready datasets with complete, unbroken audit trails for regulatory submission.

Ideal Use Cases

• Multi-site clinical studies
• Academic and investigator-initiated research
• Complex protocol designs
• Device and diagnostics studies
• Remote and hybrid data capture environments
• Regulatory submission-ready trials

OpenClinica EDC is available with flexible, study-based pricing packages designed to fit varying study volumes and protect research budgets. All packages include customer success management (CSM) support and 24/5 application assistance. Teams can build studies independently or leverage OpenClinica's professional services, with training consultants and programming support available to help navigate and optimize the platform.