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Available as a cloud solution, customers benefit from rapid and efficient EDC (Electronic Data Capture) deployment without high upfront costs, system investment or ongoing maintenance issues. The DataLabs EDC solution means total flexibility and ease-of-use for customers of all types and sizes.
Targeted Source Data Verification
• Focus resources where they are needed most through pre-defined thresholds and alerts
• Define sophisticated source data verification plans on multiple levels - study, site and patient
• Adjust the SDC plans at any point during the study lifecycle based on data quality or site performance without requiring study updates
• Provides centralized location within DataLabs to review, edit and submit case safety report for analysis and processing
• Allows users to include or exclude specific data that may be relevant to the SAE case prior to the submission to the safety system
• Provides real-time notification of critical safety events that are time-sensitive for processing
Study Design Comparison
• Dynamic user interface compares side by side study design objects within the same study, to a different study or to your standards
• Eliminate manual comparisons and reduce validation time required to review design changes
• Simple drag-and-drop features to configure CRFs, coding dictionaries, code lists, derivations and more
• Centralized repository of study design objects and metadata
• Import previous study designs using XML
• Reuse components from existing studies
Randomization and Trial Supply Management
PAREXEL® Informatics provides automated randomization and supplies management through its ClinPhone® RTSM (Randomization and Trial Supply Management) solution. Our services are offered by the industry's most experience and trusted provider of IVR (Interactive Voice Response) and IWR (Interactive Web Response) technologies.
Electronic Clinical Outcome Assessments (eCOA)
Clinical Outcome Assessments (COAs) measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions. COAs can be used to determine whether or not a drug has been demonstrated to provide treatment benefit. COA types include ePRO (electronic Patient Reported Outcomes).