■ Fragmented, disconnected processes, IT systems and approach
     -- Product complaints separate from Adverse Event systems and from Investigation/CAPA systems 
     -- Separate websites to access for coding adverse events (for e.g. – MSSO for MedDRA) 
■ Insufficient closed-loop processes result in FDA warnings and consent decrees
■ Multiple sites with their own Adverse Event reporting processes lead to lack of standardization and corporate control 
■ Homegrown electronic systems (Excel, Access) that lack sophistication to address growing needs 
of the business and evolving regulatory requirements 
■ Lack of real time visibility in to data sources 
■ Lack of access to metrics in real time(trends/analysis) results in delaying critical decision

■ What are the minimum components needed for an ideal, robust, and complete Adverse Event Reporting System 
■ How built in capabilities such as out of the box forms and MedDRA integration enables users to shorten the adverse event coding process – a result which is very critical in meeting time-sensitive reporting requirements
■ How built-in analytics provide the ability to analyze adverse events and product issues, and proactively identify and predict patterns, thus enabling the research group to improve product safety
■ How Pilgrim's system enables companies to reduce safety and compliance risk for multiple product types, including drugs and combination products, by providing a central platform for capturing the case data, regulatory reporting, analytics and related investigations