Data Management system activities are run on globally proven and specialized software like Oracle Clinical 4.5, Oracle Thesaurus Management System with MedDRA dictionary and SAS. To ensure that our data management capabilities meet stringent quality standards, we validate our clinical databases and software in compliance with the regulatory bodies and 21 CFR part 11 environments.
Services under Data Management include:
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Case report form design and Review
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Data management plan
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Database setup & validation
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Double data entry
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CRF Log and Tracking
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Clinical Data Review
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Query Management
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Interim Analysis
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Coding in MedDRA
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SAS programming
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QC check
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Database lock