I recall a senior executive of one of the world’s largest consumers of data proudly proclaiming in a much-celebrated announcement that went something like this: “We’ve made the bold decision to migrate our data to the cloud. This move will dramatically improve our information sharing because the contributing data will be stored in a common environment.” That was in about 2012, a long time ago in IT years! No one seemed to notice, however, that it’s not the physical location of data that enables “information sharing.” What happened is that multiple “data clouds” stood up, and data within each of these clouds was still isolated. That is, myriad data collections resided in the cloud(s), but were not related; they remained disconnected. One could say “data islands in the ocean called the cloud.”
The FDA has adopted the CDISC SDTM standard for clinical trial submission. While the standard has the potential to simplify the reporting processes, adoption poses challenges to and raises questions for pharma companies testing their medicines in the clinic. In response, organizations have tasked groups with managing clinical trial metadata in compliances with these standards.
We at Cambridge Semantics have been working with these groups to address these challenges with Anzo Pharma SmartBench, a user-driven platform for developing flexible data collaboration, integration and analytics solutions. Anzo Pharma SmartBench is based on Semantic Web Technology – the same standards used by CDISC to represent SDTM.
Anzo Pharma SmartBench features –
As FDA outlines, “the submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product,” and adopted CDISC standards based on semantic technology to be the standards for submitting and using study data. They further “envision a semantically interoperable and sustainable submission environment that serves both regulated clinical research and health care.”