clinIT’s data warehousing process provides business intelligence tools that facilitate the retrieval and management of metadata across studies and projects.

The overall service description for the specification, implementation, roll out and ongoing provision of the data warehouse in question is understood as a three-level service, with

• a multiple stage consultancy phase, resulting in the definition of a customer- or project-specific generic data model,
• an implementation phase, resulting in the compilation of the study data base and, finally,
• the productive phase, in which studies are integrated into the study data base.

In the productive phase, each study is set up, conducted and analyzed according to the following procedure:

• Order / protocol generation
• eCRF generation observing the CDISC-based generic data model
• Study conduct (with CRO involvement on demand)
• Transfer into the study data base
• Analysis
• Archiving

Based on the structured and consistent study data base, you are able to perform/request

• Ad-hoc analyses
• Pooled data analyses

at any time throughout the lifecycle. Additionally, these analyses can be requested on short notice, allowing short reaction times to urgent needs, such as pressing questions from authorities, physicians or other organizations. You can use this invaluable collection of data – the full body of knowledge of all clinical trial results – at any time for the

• Planning of new projects
• Generation of hypotheses
• Re-analysis of expectations.

For cost-effective analysis of the predefined models and CDISC SDTM data, clinIT provides standardized analysis programs, which enable rapid and cost-effective standard analysis for clinical studies that are part of the study data base.