EDCXtra

EDCXtra™ is a comprehensive, web-based clinical trial data collection platform developed by Clinical ink. Built on over 17 years of direct data capture (DDC) and eSource expertise — and validated through multiple FDA approvals — EDCXtra™ unifies DDC, EDC, eCOA, and eConsent into a single, GCP-compliant environment. It is designed for both clinical sites and sponsors seeking to eliminate transcription, reduce operational burden, and accelerate study timelines.

EDCXtra™ delivers a powerful, intuitive platform for electronic data capture of eCRFs and eCOAs, enabling immediate high-quality data collection, real-time data review, and intelligent automation across the full clinical trial lifecycle. By consolidating multiple systems into one seamless solution, it reduces complexity while enhancing compliance and data integrity.

Core Platform Capabilities

• Unified Platform Integration: Combines Direct Data Capture (DDC), Electronic Data Capture (EDC), electronic Clinical Outcome Assessments (eCOA), and eConsent into a single application, eliminating the need for multiple disparate systems.
• Real-Time Data Capture and Analysis: Enables immediate data entry and access, supporting real-time monitoring, faster decision-making, and enhanced data quality throughout the study lifecycle.
• Advanced Query and Monitoring Tools: Includes automated query management, targeted data review, and cross-field and cross-form edit checks to streamline data cleaning and ensure protocol compliance.
• Form Libraries and Build Efficiencies: Utilizes standardized form libraries to accelerate study builds, reduce setup time, and ensure consistency across trials.

Key Benefits for Sites and Sponsors

• Eliminates Transcription and Reduces Errors: Direct data entry at the point of care removes the need for paper source documents and transcription, significantly lowering the risk of data entry errors and reducing Source Data Verification (SDV) efforts.
• Enhances Site and Sponsor Efficiency: Reduces site workload by up to 20%, cuts query volume by 40%, and decreases monitoring time by 38%, resulting in both direct and indirect cost savings.
• Improves Compliance and Oversight: Built-in validations, audit trails, and regulatory compliance features — including GCP and 21 CFR Part 11 — ensure high-quality data and readiness for regulatory inspections.
• Accelerates Study Timelines: Real-time data availability and streamlined workflows lead to faster database locks and shorter study durations, with data available for cleaning up to 14 days sooner than traditional EDC approaches.

Regulatory and Compliance Framework

• Fully GCP-compliant environment designed to meet regulatory standards including 21 CFR Part 11.
• Comprehensive audit trails support inspection readiness and data integrity requirements.
• Incorporates Clinical ink's industry-leading eCOA and eConsent solutions within a single validated platform.

EDCXtra™ is offered by Clinical ink as a web-based solution that integrates seamlessly into clinical trial operations, supporting sponsors and sites with a unified toolset that spans data capture, patient-reported outcomes, and informed consent — all within a single compliant platform built on decades of eSource innovation.