End-to-end management of central & local lab configurations, reference ranges, and automated lab data imports for clinical trials.
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The module ensures all lab results are standardized, validated, and fully traceable.
Define labs as Central or Local, associate local labs with sites, and ensure full traceability across all study environments.
Maintain lab-specific normal ranges by age and gender, upload via templates, and automatically validate results to flag out-of-range values.
Seamlessly upload and map external lab data files (e.g., Excel) directly to subject CRFs, with automated data mapping and validation.
Upload lab datasets frequently with options to overwrite or skip existing values, while automatically updating CRF status and generating audit trails.
Ensure lab-defined reference range integrity, automated discrepancy flagging, and accurate lab-to-CRF data flow for cleaner data.
Maintain complete, regulatory-grade audit trails on every lab data update, ensuring full compliance and data integrity.
Define and manage all central and local labs participating in the study, ensuring a single source of truth for all laboratory entities.
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