Automated communication of adverse event information between clinicians and drugmakers is the function of the Rave Safety Gateway, a module for the Medidata Rave EDC/clinical data management system. The module eases the task by maintaining automation in a system prone to manual interventions.
IT consultancy Gartner finds that the module opens a communication channel between clinical sites and safety teams, and that communications leverage the International Conference on Harmonization E2B standard for pharma safety data. The module "provides a way to eliminate the issue of having to capture safety event information outside the EDC system, fax or print the information, and rekey it into safety reporting systems," writes research VP Steven Lefebure, in a research note.
He adds that the module provides "a more natural process for clinical investigator sites that fits within their current workflows" for adverse event reporting. And it can provide a case perspective, helping drug developers organize related adverse events.
- here's the research note