Phase Forward has released version 7.2 of its Empirica Signal product, a member of its Empirica pharmacovigilance and risk management product collection. Signal is a signal-detection data mining and knowledge-management tool.
Phase Forward knows pharmacovigilance: It's the chief architect of the pharmacovigilance and risk management products rolled out by the FDA--Empirica Study and WebSDM 3.0 software--for use in its validation and review of submission data in CDISC Study Data Tabulation Model (SDTM) format, as reported last November.
The release of the signal detection and management software updates the Topic Tracker module, which aids safety experts in creating records of signals and other topics of interest, including those identified outside the Empirica Signal environment. Empirica user Alcon Labs says in an announcement that the upgrade aids the company in managing product safety "in a controlled, compliant manner throughout the product lifecycle."
Users can collect supporting analyses and documentation via configurable signal management workflow capabilities to direct system responses. The upgrade includes support for Topic actions, additional permissions and administration options for managing workflow, and new management reports.
- see the announcement