Clinical Safety, Administration and Data Systems: How Should They be Integrated?

Abstract

Many pharmaceutical companies invest a great deal of effort in systems to manage clinical data, systems to oversee the planning and management of clinical trials, and systems to handle adverse event reporting, both clinical and spontaneous. This paper discusses various aspects related to the integration of these systems, both political and technical.The first question to address is should these systems be integrated at all? It is likely that within even a small drug company, the responsibility for these systems lies within different departments. There may be a clinical data management group, a medical surveillance and reporting group, and another group of clinicians responsible for the overall development process. There is a benefit in linking these functional areas, through automated data feeds and consistency checks. The three systems, however, remain independent, and the three departments involved own and control their own data.A critical aspect to the integration process involves the use of a centrali...