Managing Clinical Laboratory Data Flow

Abstract

This paper describes the practicalities of electronically transferring laboratory data from a central laboratory to a pharmaceutical company. Electronic transfer of data is a valuable technique throughout the development of a new drug: from early safety evaluations of novel compounds in Phase I trials, to major long-term Phase II and Phase III safety and efficacy trials. It is especially useful when working with dedicated contract research organizations, where large volumes of clinical laboratory data are exchanged. The benefits of electronic data transfer, however, can only be realized fully if the process of information flow is well managed.

This paper considers how to maximize the benefits of electronic data transfer through: effective collaboration, understanding and optimizing the process of getting information from its source to its destination, controlling the flow of information, validation of systems handling laboratory data, and using risk management techniques.