Data Warehouse Project for Clinical Data in the Pharmaceutical Industry Sylvia Pratz and Dipl.-Ing. (FH) Karlheinz Dreher
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach (Germany)
The analysis and reporting of data collected in clinical trials is a c rucial part in the lifecycle of a drug. Trial data analysis must be controlled and must deliver reproducible results. Special emphasis has to be paid to a controlled environment that complies with 21 CFR Part 11.
This article describes a project set up by a pharmaceutical company (Boehringer Ingelheim) in order to develop an integrated system for clinical data building, storage, analysis, and reporting on an international basis. A partnership with Oracle Corporation (Oracle®) and IBM® was formed with the goal of developing a commercially available product called Clinical Data Repository (CDR). The following article starts with a brief description of the existing setup, which was taken as the starting point for the requirements for the new application. Then, it continues with a discussion of the requirements, the functions of and process supported by the system, and its technical implementation.
The article concludes with an overview of the project, describing the challenges that lie ahead and outlining possible future applications of CDR.
Key words Clinical data, analysis, reporting • Clinical Data Repository (CDR)
