Many organizations find it hard to standardize their clinical data in the Clinical development Landscape. In reality, the standards repositories used by most pharma research organization are focused around a very specific areas (such as Data Management) while other areas are free to ‘invent’. Such patchy approach to standardization in the Clinical Development Landscape results in the executed clinical projects with trials which data is hard to compare without a significant effort.
If the standards themselves, were integrated along the clinical development chain then the Clinical Protocol Standards would drive the entire clinical development chain and the integrated clinical standards would all play in tune.
In order to achieve that, one needs to have a ‘smart’ Standards Repository, where all standards are not just defining the relevant standards for the specific area but also are aware of the context in which they ‘live’ and which other standards are required.