What are the factors that compel a PVO to make a decision of such significance?

At the core of all pharmacovigilance organisations (PVOs) is the safety database (SDB) system used to capture, assess and report adverse events (AEs) to regulatory authorities worldwide.  Effective execution of AE processing, reporting to authorities and the broader analysis essential to signal detection and risk management are heavily dependent on system functionality.  An evolving global regulatory environment is creating new challenges and business requirements, increasing the importance of system flexibility and vendor responsiveness.

In January 2006, WCI conducted a survey of pharmaceutical and biotechnology organisations to gain better insight into the influencing factors that compel a company to change safety database systems.

If you would like to read the article in full please click on the pdf. link below;

What compels a company to change Safety Database Systems?