The Situation: After many years of organic growth, this biotechnology company’s expansion in global development initiatives increased many-fold over the previous five years. For a long period, systems were implemented somewhat ad hoc to solve problems of the day. As the business accelerated, more and more human capital was needed to tackle the increasing volume of studies and submissions. This required diligent attention to numerous manual processes with a plethora of spreadsheet trackers, word of mouth communications, data movement via spreadsheets, data re-entry, etc. Business growth inevitably precipitated the need to consider more effective means of managing the increase in development studies and submissions, as well as all of the supporting activities, and in particular, the management of data.