LabKey EDC is a modern electronic data capture (EDC) software platform designed to streamline clinical trial data management. It provides a secure, user-friendly environment for capturing, integrating, and analyzing participant, sample, and results data. Built to support data-intensive clinical trials, LabKey EDC centralizes disparate data sources into a single repository, enabling quality control, regulatory compliance, and insightful reporting.

Features

• Customizable EDC System: Tailor workflows and data collection tools to meet the unique needs of any clinical study.
• Clinical Data Capture & Alignment:
  • Centralize assay, sample, demographic, and clinical data from multiple systems.
  • Import CDISC formats, REDCap files, and CRF data.
  • Use ontologies to align data with controlled vocabularies.
  • Automate data capture via APIs, pipelines, and file upload triggers.
• Analysis & Reporting:
  • Built-in plotting and reporting tools.
  • Integrations with third-party platforms.
  • Support for R scripting to generate live reports.
• Data Quality Control:
  • Use validators and range checks to ensure data integrity.
  • Automate QC checks and cleanup.
  • Generate QC reports and define workflows to support internal standards.
• Clinical Data Compliance:
  • De-identify PHI using ID randomization, date shifting, and clinic name masking.
  • Granular access controls at column, participant, dataset, and study levels.
  • Role-based permissions and full audit logging.
• Sample Management:
  • Track sample lifecycle: receipt, aliquoting, storage, and shipment.
  • Standardize lab procedures with workflows.
  • Maintain audit-ready logs and chain of custody.

Benefits

• Streamlined Data Management: Consolidate and align data from multiple sources for efficient analysis and reporting.
• Regulatory Compliance: Built-in tools support HIPAA and CFR Part 11 compliance, ensuring secure and audit-ready data handling.
• Improved Data Quality: Automated QC processes and validation tools enhance data accuracy and reliability.
• Enhanced Collaboration: Centralized data and customizable access controls support secure, multi-site collaboration.
• Scalable & Flexible: Adaptable to studies of any size or complexity with configurable integrations and workflows.
• Insightful Analytics: Native and third-party tools enable real-time data visualization and informed decision-making.