Transforming Clinical Trial Data Collection
Introducing EDCXtra™
Based on the company’s best in class direct data capture (DDC)/eSource platform, which has evolved over 17 years, and resulted in multiple FDA approvals. EDCXtra™ incorporates all existing DDC functionality into a single web-based application which includes Clinical ink’s industry leading electronic Clinical Outcome Assessments (eCOAs) and eConsent solutions, providing a comprehensive, all-in-one GCP compliant platform.
EDCXtra™ delivers a powerful, intuitive, and GCP compliant environment for electronic data capture of eCRFs and eCOAs, enabling immediate high-quality clinical trial data collection, real-time data review, and reduced operational burden. With built-in automation and intelligent workflows, it minimizes errors and maximizes efficiency across the clinical trial lifecycle.
Revolutionize Clinical Trials with Seamless, Real-Time Data Capture
EDCXtra™ unifies DDC, EDC, eCOA, and eConsent into one powerful platform—eliminating transcription, accelerating timelines, and enhancing compliance for both sites and sponsors.
Eliminates Transcription & 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 & 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 & Oversight
Built-in validations, audit trails, and regulatory compliance (e.g., GCP, 21 CFR Part 11) ensure high-quality data and readiness for inspections.
Accelerates Study Timelines
Real-time data availability and streamlined workflows lead to faster database locks and shorter study durations—data is available for cleaning up to 14 days sooner than traditional EDC.
Key Features
Unified Platform Integration
Combines Direct Data Capture (DDC), Electronic Data Capture (EDC), electronic Clinical Outcome Assessments (eCOA), and eConsent into a single, seamless platform—eliminating the need for multiple systems and reducing complexity.
Real-Time Data Capture & Analysis
Enables immediate data entry and access, allowing for real-time monitoring, faster decision-making, and enhanced data quality throughout the study lifecycle.
Advanced Query & Monitoring Tools
Includes automated query management, targeted data review, and cross-field/form edit checks to streamline data cleaning and ensure protocol compliance.
Form Libraries & Build Efficiencies
Utilizes standardized form libraries to accelerate study builds, reduce setup time, and ensure consistency across trials.
Discover more about EDCXtra™
