MEDICT (data pharma)

Digital ubiquity has transformed the way biopharmaceutical companies conduct clinical trials.

With the increase of data volume and diversity, accurate data sharing and interoperability is challenging. These difficulties do not arise from a lack of standardization, but are due to multiple parallel existing standards, often resulting in confusion among users and fragmentation of the adopted standards. MEDICT, a metadata management platform for digital clinical trials, offers an innovative way to curate standards: it introduces the concept of a Dynamic Standard, which is ever changing as further specifics are defined. A consortium of specialists from regulatory agencies, pharmaceutical industry and academia contribute to the platform with their field of expertise. A graph database of the definitions obtained (i.e., node is a definition – e.g., sensor, device –, connection is a relation between definitions, e.g., sensor is a device), coupled with vote-based weighting, is then used to make inferences on the standard itself. This allows the consortium to manage changes and accurately estimate the impact of future releases of the standard.

The MEDICT platform provides all editor tools as well as admin tools for the evaluation of new definitions and works with all common browsers in any device. Except for front-user tools, MEDICT also features an API for 3rd party application development and functional use for validating unknown dataset definitions. Special database access is also provided though the Bolt protocol for in-depth and real-time semantic analysis of the definitions’ network. MEDICT provides the pharmaceutical industry with a centralized and dynamically managed standard for digital clinical trials. We are currently running the global Consortium and further developing MEDICT.