A Case for (Clinical) Data Quality
Recognizing that scientific decisions about the safety and efficacy of biopharmaceutical products can only be evaluated by analysis of clinical data, it becomes critical that the data be of a high quality and that the information regarding this quality be transferred to the regulatory agencies. Developing metrics and procedures for evaluation of data quality throughout the biopharmaceutical-development process could enable regulatory decision makers to evaluate the confidence level of decisions made based on the data. In this interactive session the presenter will provide a brief overview of the current issues and why change is needed, highlight the concepts and current work of the Data Quality Research Institute, and discuss processes that are needed to assure data quality from a software engineering perspective.