With the need to develop Therapeutic Area standards and the subsequent launch of the CFAST initiative, it quickly became evident that the process of defining Therapeutic Area data standards for a multitude of disease areas would require improved tools and capabilities that could not be fully met by the previous manual data standards development process. In particular, Therapeutic Areas need to capture patterns of data that may not currently exist in published domains, and match specific controlled terminologies for observations relevant to specific symptoms, diagnoses, tests and assessments. Moreover, many research concepts need to be reused across Therapeutic Area studies, and the breadth of information covered across these research areas may involve tens of thousands of unique concepts that need to be represented (often with customization) in protocols, CRFs, tabulations and analysis files. It quickly became clear that such an ambitious undertaking was unlikely to succeed unless a robust systems environment like CDISC SHARE could be made available.