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Data management plan


CRF design, annotations and validation


EDC


Data Management Committee & Study Support Center


Queries generation, DCF submittion


PhV handling & Safety Reports


CDISC, SDTM and ODM standards


Statistical Analysis



Queries generation, DCF submittion

Infoset provides the complete service of data validation based on predefined criteria (protocol or logical violations, missing fields and others). Data Clarification Forms (DCFs) are generated electronically and can be resolved by the investigator on i-CDMS. All queries are tracked and identified with Query Lifecycle Statistics (QLS) metadata. Data managers, monitors, and CRAs know in real time the exact status of queries and can follow the audit trail of the changes.