WCI survey to gain better insight into the influencing factors

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.

SDB infrastructure consumes a significant share of the total investment in drug safety activities, and replacement has far-reaching organisational impact.  An implementation on a medium/large scale will likely:

• Cost $10-15+ million in capital expenditure
• Require 35-40 fulltime equivalent staff for 18-24 months
• Consume business and IT resources needed for day-to-day operations
• Require extensive effort to engage stakeholders both internal and external to the PVO, as well as external to the business itself, such as license partners and affiliates.

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

In January 2006, WCI conducted a survey of pharmaceutical and biotechnology organisations to gain better insight into the influencing factors.

To read the findings in full, please click on the pdf link below:  

What Compels a Company to Change Safety Database Systems?