An Integrated Approach to Adverse Event Data Management

This paper presents an approach which allows companies to deal with some of the major problems associated with adverse event data management in both an effective and efficient way. It is based upon discussions with representatives of severalpharmaceutical and device manufacturing companies. The approach integrates adverse event data management with other, related activities in: procedures, systems, and organization. It provides sharing of data, work flow management, and document management. The benefits of such an approach are speed, efficiency, and auditability.