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SAE - Safety Data Reconcialiation

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 Safety Data (SAEs) Reconciliation Solution Designed for Compliance and Flexibility

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.

Cloud Based or On Premise Application 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