Rave Safety Gateway is a configurable EDC-to-safety system interface that streamlines the end-to-end workflow management of safety data in clinical trials. It automates the collection, transmission, and tracking of Adverse Event (AE) and Serious Adverse Event (SAE) data from Rave EDC to safety systems, significantly improving the speed and accuracy of safety data capture and reporting.

Key Features

Automated Data Transfer Automatically delivers data from Rave EDC forms to safety systems

• Eliminates manual data re-entry
• Reduces transcription errors

Configurable Mapping Allows customized mapping of EDC fields to safety case elements

• Flexible configuration of data transfer
• Supports ICH E2B R2 and R3 formats

Timed Trigger Transmission Ensures timely reporting of adverse events

• Configurable automatic transmission after predefined time
• Fail-safe mechanism for unsigned data

Benefits

Improved Accuracy Reduces errors in safety case data

• Eliminates transcription errors
• Enables 98% accuracy in coded terms using Rave Coder

Accelerated Reporting Speeds up safety data transmission and processing

• Reduces query cycles and reconciliation efforts
• Enables faster safety case triaging

Reduced Burden Lightens workload for clinical trial sites and teams

• Decreases manual data entry and reconciliation
• Streamlines adverse event reporting process