BioPharm Systems has launched an Oracle Health Sciences Empirica Topics accelerator, Accel-Tracker, for the management of information associated with potential pharmacovigilance signals.
The pre-configured version of Oracle Health Sciences Empirica Topics uses BioPharm's methodology to facilitate the formal prioritization and evaluation of signals identified within a company.
BioPharm Systems safety and pharmacovigilance vice president Rodney Lemery said the European Union has introduced new pharmacovigilance regulations requiring companies to strengthen their efforts on the documentation surrounding the detection, prioritization and formal evaluation of signals by July 2012.
"Having the ability to provide an agency with objective evidence on the entire signal management process will become a critical part of safety and pharmacovigilance work," Lemery added.
Oracle Health Sciences Empirica Topics and Accel-Tracker, together, can help protect an organization in an audit and ensure it has a well-established methodology for signal management, the company said.
