A Case Study on the Vigilance Project

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I. Background of the Case
Headquartered in France, PharMed International is one of the world’s largest pharmaceutical companies. It was established two years ago when two formidable pharmaceutical companies, ValMed and PharmCO, combined. Although officially termed a merger, in practice, it might better have been described as an acquisition of ValMed, a Swiss-based company with extensive U.S. operations, by PharmCO, a French-based company. Like all pharmaceutical companies, PharMed is obligated to keep detailed records of how its drugs perform. To do so, PharMed relies on sophisticated database systems that track and record adverse events associated with the use of its products under development and already in the market. The Drug Safety Division of PharMed is charged with fulfilling this obligation. The division is headed by Lance Paulson, M.D. Paulson is based in the United States, but the division has managers and employees in numerous countries. Paulson’s deputy director, Francine D’Aubigne, M.D., is located in France. The Drug Safety Division is in the process of implementing a new adverse event database system called Vigilance, which will be used by division employees around the globe. The data entered into the system will be used to generate reports the company is obligated to provide to various regulatory agencies around the world (in the United States, for example, that agency is the Food and Drug Administration). The two-year project began about one year after the merger. The core team responsible for designing and implementing Vigilance has three members in the United States and four members based in France. They include employees from the Drug Safety Division, as well as employees from the company’s Information Systems (IS) Division who are dedicated resources for the Drug Safety Division. In addition to the core team, five subteams were formed. These subteams each have a user lead from the Drug Safety Division and an IS lead, and report directly to the user lead (Karine Bareaut) and IS lead (Merline Bucquet) respectively. Each team also has two to four additional members, most of whom are involved with the project on an intermittent basis. Overall, half of the subteams’ members are located in the United States and half are based in France.

Most of the U.S. core and subteam members were previously employees of ValMed. At the project’s start, they were looking forward to working on this initiative. Before the merger, several of them, including all of those on the core team, played key roles in efforts to develop a similar system called Perspective. The work had been intense and time-consuming, but the team members were stimulated by that project. They put in long but collaborative hours and were nearly finished when the merger occurred and implementation of Perspective was put on hold. Several months later, the newly merged organization decided to scrap Perspective in favor of Vigilance. There were two main reasons. First, having been designed before the merger, Perspective’s capacity was too small to accommodate the needs of the larger organization created through the merger. In addition, it was not clear that Perspective’s design could support the new business processes (e.g., workflow procedures) that were implemented post-merger. The Perspective team members were disappointed, but understood the rationale for the change in direction. As work on Vigilance began, those who had been a part of the previous project looked forward to sharing the benefit of their experiences. Not long after work on Vigilance began, however, their enthusiasm waned. The Vigilance core team, some of whom had worked together before, started the project by holding a one-day, face-to-face kick-off meeting in Paris at the corporate headquarters. Meeting as one large group, all project team members attended, including those on the subteams. There were formal introductions to ensure everyone knew each other. The roles of the various...
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