Safety Case Transmission & Reconciliation

A critical quality step in clinical trials is ensuring that the safety case transmission and reconciliation between electronic Data Capture (EDC) systems and safety systems are operating correctly. The process confirms that Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSARs) are transmitted to regulatory agencies to monitor safety signals and develop the drug safety profile.

For the electronic submission of Individual Case Safety Reports (ICSR), the global standard for safety systems to government and regulatory agencies is ICH E2B. Adherence to the E2B standard allows for the worldwide exchange of information quickly and accommodates direct database-to-database data transmission.

Discover how teams can reduce manual efforts and increase the speed and accuracy of safety case reporting by automating safety case synchronization and reconciliation.