Driven by legacy paper-based approaches, the design, conduction and analysis of clinical studies requires the creation and transformation of many data in many different formats. This hinders the process and necessitates significant resources. Having metadata-driven transformation is not new, however adoption of standards (.e.g CDISC) has not shown yet its full added value. We propose to extend this metadata-driven approach beyond CDISC standards from the writing of the unstructured clinical study protocol to submission of the clinical study report to health authorities. By sharing and re-using metadata end-to-end of the drug development critical path, we shorten and automat key tasks hence improving the efficiency of the overall process.
Over the last 25 years, we have accumulated a lot of clinical data for one primary purpose that was submission to regulatory authorities, the package supporting some efficacy and safety claims. But this data contains much more information. Cedric Berger is a scientist in training and he currently believes our "Current approach to data governance does not work well" and he is here to present his talk about his experience. He provides certain points about the data governance as it is now, and he provides what he thinks is good for businesses which is a governance framework. This culminates to Cedric explaining how the governance can be applied to clinical models showing benefits of the application. #knowledgegraphs #knowledgegraphconference #knowledgegraphsintheoryandpractice #knowledgegraphinhealthcare