Safety reporting is one of the least efficient aspects of clinical trials today. The current approach places a heavy, sometimes unmanageable, burden on sites. Sponsors bombard them with safety notifications, many of which are superfluous or otherwise unnecessary.
The entire process is ripe for error, and the consequences can be severe. One mistake can lead to regulatory repercussions, delays—even having a trial go into rescue or to be shut down.
In 2014, Celgene decided to upgrade its safety document distribution system to address some of these issues. After researching several options, Celgene chose WCG Clinical's SafetyPortal.