An Integrated Approach to Adverse Event Data Management

Autor: Robbert P. van Manen
Rok vydání: 1996
Předmět:
Zdroj: Drug Information Journal. 30:731-736
ISSN: 0092-8615
DOI: 10.1177/009286159603000316
Popis: 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 several pharmaceutical 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 audit-ability.
Databáze: OpenAIRE