e-DATAM - electronic clinical Data Management

    The e-DATAM functionality makes it possible to use a true multidisciplinary approach to data management. Site personnel, medical and non-medical data management teams and Clinical Research Associates (CRAs), each having their specific role in the data management process, can use this feature collaboratively to deliver complete and accurate data in the most time efficient manner.

Electronic Data Management commences during electronic data capture using focused, pre-defined and validated online queries. This important step allows for the early detection and correction of inconsistencies and thereby reduces the workload for both site and data management teams. Hence, the need to create electronic data clarification forms (e-DCFs) for such inconsistencies is obsolete.

Our experienced clinical and non-clinical data management teams work together on an ongoing basis to execute complete data management activities. This approach enables simultaneous medical and non-medical data checking and coding of medical terms / concomitant treatments which increases productivity and accelerates the timetable to declare data clean. During the data management process, e-DCFs are created and posted as required with automatic notifications being sent to site personnel for e-DCFs requiring urgent resolution. The data management workflow is data driven and streamlined using detailed task lists. Scheduled visits and multiple data records (e.g. concomitant treatments, adverse events, and unscheduled visits) that are declared clean following the data cleaning process are locked on an ongoing basis.

This approach to data management reduces the time to final database lock after the last patient visit. It also ensures the availability of accurate and complete data for interim analyses and/or status reports which may be required during the conduct of a research project.

Key features and benefits of e-DATAM are: Ensures a true and active multidisciplinary approach to data management Automatic notification to the data management team of tasks to be performed Concurrent data management and coding of medical terms and concomitant treatments on an ongoing basis ensuring punctual, quality data Simultaneous medical and non-medical checking of data Automatic site notification for e-DCFs requiring urgent resolution Complete audit trail of all created e-DCFs Clean data locked on an ongoing basis Time to complete database lock substantially reduced Preparation of interim analysis reports using accurate and cleaned data

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