Medidata Rave®

Capturing Data | Managing Data | Reporting Data | Building Studies | Site Monitoring | Safety
 

Safety Gateway—Speed Submission of Adverse Event Data 

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

Minimize Reconciliation Between Safety and Clinical Databases

By integrating electronic clinical data capture, safety data 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 Safety Data Query Cycles

Rave Safety Gateway substantially reduces the number of queries safety staff need to issue sites to triage cases as well as shortens query cycle times. The integrated data collection approach decreases the amount of incomplete or inaccurate data that often leads to query cycles. Common data visibility for both safety and site staff greatly speeds query resolution.

Streamline Post-Marketing Expedited Reporting

With the capability to electronically transfer both non-serious and serious safety case data from sites to safety systems, Safety Gateway helps pharmas meet the new European regulation requirements for post-marketing expedited reporting.

Automatically Notify Predefined Personnel

Immediately upon site staff entering new or follow-up safety data in the EDC system, Rave Safety Gateway can extract relevant safety 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.

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 data and select which is to be included in the E2B file. When E2B Plus is supported by the safety system, Rave Safety Gateway can be configured to extract supplementary EDC data not covered by the E2B standard. All mapping and data activities in Rave Safety Gateway are logged for audit purposes.