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eReconciliation® for Safety Data Reconciliation

Flexible SaaS solution for high-volume SAE data reconciliation

eReconciliation® is a highly automatable software solution for SAE Reconciliation, that helps you save tremendous time, minimize errors and prevent major compliance breaches.

Why should you need to start SAE Reconciliation process early?

SAE data reconciliation is not just about automating the process of data comparison at the end of the study. It’s about doing it early and regularly, with minimal human input, to save precious time at clinical database closure.

Equipped with automation features, smart tools, hands-on task management features and a secured audit trail, eReconciliation® allows data management, clinical and safety teams to perform SAE data reconciliation all along the study with minimum burden, simplifying operations management, supporting data quality and guaranteeing GxP compliance.

Automatically Import & Compare SAE Datasets from any DB

Once the datasets are imported in the system, records are displayed in a side-by side view of the clinical and safety datasets.
The system can automatically create groups of reconciled records based on level of relevance.

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Automatically create groups of reconciled records

Based on level of relevance, eReconciliation® allows to automatically create groups of reconciled records. Groups that did not totally satisfy the rules can be reviewed by a team member who will check what needs to be fixed.

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All-in-one operation management tools

Allows managers to follow all tasks at any stage (labelling, flagging, commenting, assigning actions). All involved functions benefit: Quality Assurance, Data Managers, Regulatory Affairs…

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Automated Data Update Flagging Tool

Automatically flags the record when the system detects a change in source data. Only displays the latest data so users can skip all interim changes.

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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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We are EU-GDPR compliant: Your Data will never be used improperly



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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