Maneuvering a Drifting Project Back on Course

The Situation

The NDA had been drifting within the FDA for years, and now it was subject to intense scrutiny by two agency reviewers. They required specialized statistical analyses and also a significantly different display format.

Our customer needed to present a series of 10 study synopses as soon as possible
-- not only in hard copy, but also in two different digital formats. Furthermore, the output style preferred by one reviewer could not be produced with existing off-the-shelf software. The customer called Quintiles.

The Solution

The Quintiles Biostatistics group rapidly assembled a team of statisticians who performed the custom analyses and digested the material into the necessary synoptic form. Two graphics specialists designed a special presentation format. Result: all 10 studies completed in record time. The whole process, from initial discussions to conclusion, took less than 4 months.

Value Added

The NDA was approved. The customer believes that Quintiles' facilitation of the agency review significantly moved the process toward a successful and timely conclusion.