Safety Gateway—Streamline SAE Collection & Communication

Rave Safety Gateway is a secure, configurable EDC-to-safety-system interface that enhances Medidata Rave^® EDC with advanced serious adverse event (SAE) collection and E2B transmission capabilities. With Safety Gateway, sponsors can greatly improve the accuracy, speed and visibility of their SAE collection and communication process, yielding significant savings in time and resources.

Reduce Reconciliation Between Safety and Clinical Databases

By integrating electronic clinical data capture, SAE collection and communication processes, Rave Safety Gateway streamlines the workflow between sites, safety and data management teams. All safety-related data is directly captured in Rave and can be extracted into E2B files that are consumable by any E2B-compatible safety system. The reconciliation efforts to resolve discrepancies between safety and clinical databases are minimized.

Reduce SAE Query Cycles

Rave Safety Gateway provides substantial benefits in reducing the number of queries safety staff need to issue sites to triage cases as well as shortening query cycle times. The integrated data collection approach decreases the amount of incomplete or inaccurate data that often leads to query cycles. The common visibility to same data sets in EDC shared by safety and site staff can greatly speed case resolution.

Automatically Notify Predefined Personnel

Immediately upon site staff entering new or follow-up SAE data in the EDC system, Rave Safety Gateway can extract relevant SAE case data into E2B files in near real-time and simultaneously issue email notifications to predefined personnel. Email content can be customized to include key information such as safety case ID, type and version, thus instantly providing the safety team with important case information even before contacting sites.

Configure Business Rules and Workflow

Flexibility is key to ensuring that specific safety process needs are met. Comprehensive business rules can be defined to govern parameters specific to a trial’s design. Manual override allows safety personnel to review the extracted EDC data and select which is to be included in the E2B file prior to its creation and transmission. When E2B Plus is supported by the safety system, Rave Safety Gateway can be configured to extract supplementary EDC data not covered by E2B standard. Rave-to-E2B mappings are reusable within a study or across projects.

Fully Auditable

All mapping and data activities in Rave Safety Gateway are logged for audit purposes, as opposed to comparable paper-based practices. Sponsors have full visibility into safety data that has been extracted and updated in Rave, which files have been transmitted to the safety system, what changes have been made—when and by whom—to the Rave-to-E2B mappings and the manual data reviews. E2B files for initial data transfer and subsequent follow-ups are searchable through Rave Safety Gateway.