This chapter contains as well as illustrates different innovations that is changing the way Clinical Drug Development and Safety organizations perceives IT and the ways and means through which these innovations are facilitating the change in business itself. The main content contains illustrations of two structurally different means to create data warehouses, the benefits of the approaches and the difficulties. It also explains the importance of data virtualization technology when implemented in the Clinical and Safety Organizations.
Top1. Development Of Business Case
Multiple studies has shown historically Data Warehouse project don’t have high success rate. A study published by Amin & Arefin (2010), list top 20 reasons on why 50% of the Data Warehouse projects fail, 6 out of 20 reasons listed, deals with failure to acquire right Business Case and failure to perform right stakeholder mapping at the start of the project. The main reason to include this section in detail in this chapter is to put further emphasis on the fact when building an innovative application where results could be radically beautiful on one side, on the other side, chances of failure are also high. In such conditions, the business case assumes greater importance.
The most important factor, of the whole sequence, would be for the organization and its leaders to jointly decide, on exactly what they perceive as outcome and what the measurable benefits of the upcoming system are and hence a business case should be developed. It is essential that along with the objectives of the project the Business Case includes as key success criteria; the right accountability structure within the organization as a whole (business owner) and for the project organization (project manager), right business needs, cost, and estimated business benefit to be derived, on a clear time scale. Who (business teams) gets what (functionality, reports etc.) when (timeline), for how much (cost, resource/SME allocation) should be documented. Finally the risks associated with the achievement of the project objectives is crucial to be identified and documented albeit at a high level at the very beginning, since if kept fluid, this is observed to be the single most important cause of failure of data warehouse projects. A feasibility study could be undertaken during the development of Business case. It allows for a more detailed analysis and assessment of the business problem/s to be dealt by the project team. It also support the team to identify risks and visualize possible pitfalls in advance and finally it present options to mend the solution design envisaged for the project.