EDC

LabKey EDC is a secure, user-friendly electronic data capture platform designed to holistically manage clinical trial data. Built for modern, data-intensive clinical trials of any size or complexity, it addresses the critical challenges of organizing disparate data sources, navigating fragmented data views, and managing cumbersome reporting processes. By centralizing participant, results, and sample data in a single repository, LabKey EDC enables research teams to streamline quality control, preparation for analysis, and regulatory compliance.

LabKey EDC is the trusted solution for research teams seeking to enhance operational efficiency, ensure compliance with key industry regulations, and deliver high-quality, audit-ready clinical trial data. The platform supports configurable integrations and workflows, making it adaptable to the unique needs of each study.

Clinical Data Capture and Alignment

• Centralize assay, sample, demographic, and clinical data from disparate systems and databases into a single repository
• Import CDISC formats, REDCap files, and CRF data
• Use ontologies to reconcile data with controlled vocabularies
• Automate data capture using APIs, script-based pipelines, and file upload triggers

Analysis and Reporting

• Align and quality-control data in preparation for accurate reporting and analysis
• Leverage built-in plotting and reporting tools alongside third-party integrations
• Use powerful R scripting support to generate live reports directly within LabKey EDC

Data Quality Control

• Apply data validators and range checks to verify data integrity and accuracy
• Use quality control reports to track key QC metrics across the study
• Automate quality control checks and data cleanup measures
• Define QC workflows to support internal processes and standards

Clinical Data Compliance

• De-identify Protected Health Information (PHI) by randomizing participant IDs, shifting dates, and masking clinic names
• Control access and views of data with granular controls at the column, participant, dataset, and study levels
• Apply fine-grained role-based permissions to manage access to study data while maintaining a full audit log of all actions performed in the system
• Ensure compliance with key industry regulations including CFR Part 11 and HIPAA

Sample Management

• Manage the complete lifecycle of clinical trial samples, including receipt, aliquoting, storage, and shipment
• Use workflows to standardize lab procedures and data capture
• Track chain of custody and maintain an audit-ready log of all actions performed on each sample

LabKey EDC integrates seamlessly with LabKey's Sample Manager, REDCap, and other external data sources and research tools, enabling unified workflows and datasets across the clinical trial ecosystem. The platform is designed to support regulatory compliance and protect sensitive patient data through advanced security features.