Performance Evaluation of Management Information Systems in Clinical Trials: A System Dynamics Approach

The complexity and characteristics of the pharmaceutical firm present an intriguing context for underlying information management issues during clinical trials for new drug development. This paper reports on the evaluation and performance of MIS for information management in clinical trials in new drug development. The main objective of the study is to examine the economic and business impacts of automating that process, to enhance our understanding of informational stakes involved, using a system dynamics (SD) model. The SD method is enriched in this paper with other conceptual frameworks such as Alter’s (2001) Work Centered Analysis (WCA) and the activity diagram offered by the Unified Modeling Language (UML). Results of the simulations for alternative sensitivity analyses on errors rates in data transmissions, that is, on alternative errorrate specifications, do not necessarily influence project delay, but rather work intensity. A discussion details the usefulness of enriching the SD modeling process with alternative conceptual frameworks in the problem definition in such complex settings.