MEDICT, FHNW School of Life Sciences

Digital transformation has changed the way biopharmaceutical companies conduct clinical trials. The advent of digital biomarkers (health measures collected and measured through digital devices), has generated ever-increasing data and the need for efficient metadata management platforms.

We set to address this need by creating an efficient public metadata management platform based on metadata standards for describing raw and processed data. The project aims to define the conceptual and methodological foundation) for a web-based platform application, limited to the therapeutic area of Parkinson’s disease which is of particular relevance in digital clinical trials today.

We aim to integrate two data formats that are collected in digital and traditional clinical trials for the diagnosis and prognosis of Parkinson: 1) movement data gathered by modern compact accelerometers and 2) brain MRI can aid to improve the accuracy and confidence about the diagnosis. The standard FAIR and ALCOA+ standards developed and integrated within this project covered study characteristics and protocol, cohort/subject information, sensors and endpoints. The metadata set will be scalable to allow integration of additional data and formats.

Further projects