Considerations of cost and ownership are encouraging companies in pharmaceutical research to separate their data storage from their computation needs. The widespread perception that storage is inexpensive and easily extensible compared to computing power is not necessarily correct. The real deal is that organizations should scale storage and computing separately, as they do not always rise in tandem, and thus the separation makes sense to better provide for savings. Looking at a situation more closely reveals that ownership of data used in analysis and computational processes may be more complex. A computational environment might not be considered the owner of the data it uses, and so that data is stored elsewhere. Similarly, data silos within organizations may be set up such that data cannot be used for downstream processes, so that exports or copies have to be created to perform the computations.
The desire for end-to-end traceability along with regulatory requirements have led entimo, in both its products entimICE DARE and entimICE FastTrack, to follow the principle of ownership of the data in their repository. This applies to all metadata, and also to data, which is mostly held in a central file system. Following an evolutionary path, entimICE FastTrack is designed to offer more flexibility and connectivity for external storage. Within entimICE DARE, there is still an option to store clinical data in a database, with entimICE retaining ownership.
As the size and nature of data gathered during clinical trials expand and change, the tools needed to analyze and understand that data will are also evolving. Consider the example of a trial sponsor that decides to build clinical data storage for all data that comes in from EDC systems and other sources. While the storage is organized in a fashion specific to the company, it uses approaches that are well understood. Further, the sponsor needs all other tools to interact with the data in this cluster.
Engineers are working to ensure that entimICE FastTrack can adapt to this new environment by projecting data from the storage into its own repository, following a proxy concept and other comparable methods. The software only projects relevant data, and is able to track changes on the projected data as well as mirroring this information in its own traceability records. This capability is important for keeping information needed for compliance all within entimICE FastTrack.
The combination of these approaches enables entimICE Fast Track to evolve with the changes in how organizations throughout the drug development process are addressing increasing amounts of data not only in increasingly heterogeneous formats but also data sources outside of entimICE.