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eReconciliation® for Safety Data Reconciliation

GxP Validated software solution supporting all SAE data  reconciliation operations from one or more databases in any system (RAVE, CRF, EDC, ARGUS…). 

eReconciliation® is a comprehensive software solution supporting every operation related to SAE Reconciliation: import and compare data from any data source, create groups of records to reconcile, manage tasks assignments, track source data updates in real time and record all safety data reconciliation operations in a full audit trail available in case of inspection.

Why should you need an electronic SAE Reconciliation Software?

SAE Reconciliation, when done manually, is repetitive, time-consuming and prone to errors.
With the GxP validated eReconciliation® software solution, clinical teams can manage efficiently all their operations related to safety data reconciliation and easily reconcile groups of data items in real time as changes in source data are flagged by the system. Because safety data reconciliation is performed all along the study, clinical teams save valuable time at clinical database lock.

Import & Compare SAE Datasets from any DB

eReconciliation® is a flexible software solution that can import SAE datasets from any Clinical and Safety System and display them side by side allowing to easily and efficiently compare data from one or more databases.

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Find and Link Groups of related Records

eReconciliation® allows to connect to navigate datasets detecting related SAE records, making sure that no record and no Safety information is missed out.

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Manage SAE Reconciliation with Workflows

eReconciliation® allows to easily assign Data Reconciliation tasks on different roles, set up workflows and manage staff turnover including when outsourcing is involved.

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Track & Manage SAE Data Updates during Time

By flagging any updates in the imported datasets, eReconciliation® allows clinical teams to perform SAE Reconciliation all along the course of the study thus saving valuable time at database closure.

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Manage Audit Trail and GxP Quality

As a 21 CFR Part 11 compliant software solution, eReconcilation® tracks in the Audit Trail all operations related to your safety data reconciliation. The history is available at any time in case of an audit.

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eReconciliation® features: Import & Compare SAE Datasets side-by-side

Import SAE Datasets from any Clinical or Safety database and compare data from as many sources as needed, even within the same single database.

Import & Compare SAE DatasetsREAD MORE

Computer System Validation

Ethical's eReconciliation systems, business processes and services are compliant with the appropriate regulations: GxP, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, EU General Data Protection Regulation (GDPR).

Reconciliation of Safety Data and Computer Systems' ValidationREAD MORE

The SAE Reconciliation Process: A Multi-Facet Challenge

The SAE reconciliation process can be summarized in four - apparently easy - steps: retrieve and compare data, analyze the discrepancies, resolve the discrepancies ...

SAE Reconciliation Process: a multi-facet challengeREAD MORE