Safety Gateway
Manual transfer of adverse event (AE) data between EDC and safety systems creates risk, reconciliation burden, and delays in reporting.
Medidata Rave Safety Gateway securely automates the compliant transmission of SAE and AE data from Rave EDC as ICH E2B R2 and R3 files—reducing errors, limiting reconciliation, and accelerating regulatory submission while strengthening patient safety.
Eliminate Safety Transmission Delays
Configurable Safety Case Data Mapping
ICH E2B R2 and R3
System Compatibility
Manual, Automatic,
or Timed Transmission
Automatic Notifications
Delivering Measurable Benefits
Reduce Reporting Burden
Reduce the Burden of Safety Reporting
Automatically deliver AE and SAE data from Rave EDC into your safety system with Safety Gateway.
Ease reporting demands at the site level while reducing query volume and reconciliation effort for data managers and safety teams—streamlining safety workflows across the study lifecycle.
FAQ
Is Rave Safety Gateway compatible with any safety system?
Yes. Rave Safety Gateway can transmit safety data to any safety system that is compliant with the ICH E2B R2 or R3 standards. It collects and prepares safety data into the industry-standard E2B format, making it ready for seamless import into your chosen safety system without requiring custom integrations.
Does the system allow for manual review before transmission?
Yes. You can configure the system to fit your specific workflow needs. You can choose to have data automatically exported as E2B files immediately, or set it up to require review, selection, and approval by your team before the transfer occurs.
How does Rave Safety Gateway handle coding for adverse events?
To ensure accuracy and reduce manual work, adverse event terms entered in Rave EDC are automatically coded using Rave Coder. This integration provides 98% accuracy in automatically suggesting coded terms, ensuring that the data transmitted to your safety system is standardized and compliant.
Can we configure which data fields are transmitted?
Yes. The solution offers configurable mapping, allowing you to control exactly which fields in Rave EDC are mapped to specific ICH E2B R2 and R3 elements. The system then monitors those fields to detect new data entry or updates and prepares the files for transmission based on your specific mapping rules.
Does Medidata offer training for its clients and partners?
Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.