The Merck Worldwide Clinical Data System: Domestic Data Handling

In an effort to meet Merck's clinical information needs for the future, many individuals within the company have been working for some time to develop a worldwide, distributed data processing capability. Such a system, it is envisioned, would have advantages that would serve to decrease the workload in-house following the receipt of clinical trial data. Data discrepancies could be rectified quickly if the system designers allowed for review of data close to the locale at which the source data were generated. All these features would work together, theoretically, to decrease the time necessary to prepare a new drug application. While the placement of the networked system outside the United States was and is complicated, the design was obvious, as Merck traditionally collected data there through its subsidiaries; that is, local offices that supported clinical research activities. In the United States, however, no such geographic location was in place to form a node in the network. The creation of a domestic subsidiary provided the answer to completing the structure of the worldwide system. Currently, in-house data professionals are processing data for an investigational new drug, working through new procedures daily, and adapting to the new subsidiary concept.