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Review and Compare Serious Adverse Events (SAEs) across Clinical and Safety databases with a GxP Validated eReconciliation® 

Why should clinical teams continue to review and Reconcile Safety Data manually when a  new GxP validated software can ease and improve the quality of their work?  eReconciliation® allows fast reconciliation of data from different sources such as RAVE, paper or eCRF, any other EDC – internal or external, Argus safety database, etc.

A Flexible (SAE) Safety Data Reconciliation Solution Designed for Compliance.

Clinical Data Management Regulatory Compliance

Ethical’s software, systems and services comply with all regulations that apply to clinical data management: GxP, GAMP 5, US 21 CRF Part 11, EU GMP Vol. 4 Annex 11, ISO 27001.

Flexible Configuration for System and Database Hosting

You can choose between Ethical's Cloud-Based Hosting and Server Management or Install eReconciliation Web Application on your own Data Center

Computer System Validation Support

eReconciliation® service includes a complete Software Validation Documentation Package (Validation master plan; User Requirements Specifications; Design and Functional Specifications; Traceability Matrix; Installation Qualification (IQ); Operational Qualification (OQ); Performance Qualification (PQ); Change Management, Backup and Recovery, Users Access SOPs.

Request a Demo of the eReconciliation® Software

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



Download Ethical eReconciliation for SAE Reconciliation Dossier

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SAE Handbook Download

Download your FREE practical guide on how to reconcile safety data collected from various sources and stored in more than one databases.

Download your complete safety data reconciliation handbookREAD MORE

Clinical Safety Glossary

A list of terms and definitions related to Serious Adverse Events, adverse event data management and safety and clinical databases SAE Reconciliation.

Check Now the Safety Data Reconciliation GlossaryREAD MORE

Pharmacovigilance Regulations

The quality of safety data collection and reporting is paramount to the establishment of a drug safety profile. Here are helpful links to the EMA and FDA regulations addressing those concerns.

Safety Data Reconciliation: check now EMA and FDA Regulations & GuidelinesREAD MORE