eReconciliation® is a comprehensive software solution supporting every operation related to SAE Reconciliation. eReconciliation® software allows to import and compare records from any clinical and safety database, flags changes in source data and offers operational functions that help manage all reconciliation operations. All operations are recorded in an audit trail and can be exported in Excel files. eReconciliation® main features: • Imports and compares SAE records side-by-side from any Clinical and Safety Database (RAVE, EDC, ARGUS, etc.) and shows them side by side. • Filters are at configuration to ease the navigation. • Flags changes in source data and keep the reconciliation operations always on-going. • eReconciliation® offers operational functions that help manage all reconciliation-related tasks. E.g.: - assign actions by functions (Data Management, Medical Safety, CRAs, etc.), - a comment field for each SAE to clarify the next steps and who is in charge - flags the new, changed and not yet reviewed data and the items that need resolution. - notifies of new matching items after an update in one of the source databases, e.g. following a query. • Export all reconciliation operations to Excel spreadsheets. E.g. site-specific reconciliation information that can be used in coordination with monitoring visits. • All the reconciliation operations are recorded in the audit trail. E.g. all queries regarding an individual SAE. • All actions performed in the system (e.g. commented and accepted discrepancies, site-specific SAE reconciliation queries, final summary of all reconciliation operations…) can be exported in Excel files and archived in the TMF.
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