Itec services

Data Management

Data Managers at ITEC SERVICES are fully up-to-date with clinical data methodology. They use Capture System® and keep to the Sponsor’s project schedule. The Data Management team maintains close contact with the Project Leader, CRAs, and statisticians… for guidance and optimal deployment.

Data Management is tightly linked to monitoring (project training, on-line data capture, planning…) throughout a study, so as to cope with overall demands.

Data Management => clinical and epidemiological studies

• CRF and/or eCRF design and help with data retrieval
• Installation of underlying system: ‘blind’ data capture, consistency checks, formatting SAS® tables
• Independent double-entry data by competent, trained staff
• Consistency tests and data queries, involving a close collaboration between CRAs and Data Management throughout a clinical study. Coordinated management reduces delays
• Routine medical reviews by a physician
• Installation of dynamic interactive tools for ‘blind’ review
• Final validation of the database and ‘blind’ review
• Exportation of data in the requested format (SAS®, Siphar®, ASCII…)
• Data management report
• Audit trail (ITEC SERVICES holds ISO certification), validated by multiple controls during data processing to ensure an impeccable database.

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