Mission impossible

the success story of an international pharmaceutical task force

Bringing a new drug to the US market is a difficult and expensive process that typically requires several years to complete. Achieving this in only thirteen months and for approximately US$3 million is a major achievement. And this is what Solvay Pharmaceuticals accomplished via its effort to bring a selective serotonin re-uptake inhibitor--known commercially as LUXOR tablets--to the US market. This article profiles how Solvay realized this project, which involved coordinating the review and databanking of 24,624 case record forms (CRFs)--written in different languages and prepared throughout Europe--while working with six contract research organizations (CROs) in the US and Europe. In doing so, it overviews the project's goal and evolution, listing the key project parameters that were established during a kick-off workshop; it identifies the two project concerns and ten ground rule that workshop participants determined as crucial for successfully realizing this project. It discusses how the team collected the CRFs and how it selected the CROs that participated in the project. It lists the CROs selected and describes how the team communicated with these European-based CROs. It then details how the team managed the CROs to ensure that the CROs accurately databanked the safety and demographic information obtained from the CRFs, noting the team's process for establishing quality assurance processes. It also explains how the CROs completed the managed the work performed by the European team and the US team. Accompanying this article is a sidebar detailing the structure of Solvay's Belgium, Dutch, and US operations.
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