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Biostatistical expertise and guidance during study design, implementation and final analysis
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Informatics expertise to optimize data collection efforts with effective data retrieval
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Remote and on-site monitoring of clinical data and regulatory compliance
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Development, implementation, and maintenance of 21 CFR Part 11 and HIPAA compliant electronic study specific data capture tools
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Site training and coordination of enrollment and study conduct with centralized oversight
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Report preparation for governing and oversight bodies & funding agencies
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Facilitation of communication among researchers and oversight agencies
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Standardization and quality control measures for data integrity across sites
