A Case Study on the Vigilance Project
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
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