Clinical Safety Systems
of the most critical applications for a life science company is
the Clinical Safety System. This system contains all of the most
serious adverse events experienced by patients exposed to the company's
product. Because this data defines actual risks to patients, Clinical
Safety Systems are part of a company's overall quality control system
and subject to rigorous regulatory scrutiny.
While requirements for safety reporting are well defined by regulatory
agencies, meeting these requirements is a significant challenge
for life science companies. Mature Clinical Safety Systems can help
ease the burdens of regulatory compliance, pharmacovigilance, and
product development as the safety profile emerges from a patient
Explore Consulting implements commercial safety systems such as ARISg sold by Aris Global and Argus Safety sold by Relsys. Our experience with validation of these systems reduces risks and software quality assurance costs while it improves quality and expedites implementation. We integrate Clinical Safety and Clinical Data Management Systems to improve data quality.
To find out more about how Explore Consulting can help, contact us.