Summary

The Ludwig Institute for Cancer Research is a nonprofit research organization committed to improving the control of cancer through integrated laboratory and clinical research, and novel therapeutic strategies based on the emerging understanding of cancer. Faced with the standard, paper-based severe adverse event (SAE) reporting process and a growing number of international studies, Ludwig sought to automate their system to eliminate manual data entry and reconciliation of the safety and clinical databases.

The Ludwig Institute chose to create a complete, end-to-end SAE solution by enabling and configuring Rave Safety Gateway, Medidata Rave EDC-to-safety-system interface, with EXTEDO’s PcVmanager, a drug safety management solution built specifically with open data  standards in mind. This cross-vendor solution allowed a fully electronic workflow from adverse event data entry to medical coding, triage, analysis, and agency communication.

SAE queries can be resolved quickly using the standard Rave EDC query workflows. Affiliates and large partners are able to use a familiar query interface in Rave EDC, and are able to see at all times the latest version of the safety data. Little to no reconciliation effort is necessary at the end of each trial, saving hours to weeks in reconciliation time.