Research project “Regulatory compliant document management in the Trial Master File (TMF) through artificial intelligence – NextGenTMF” 7. August 2022 DHC Business Solutions in collaboration with iOMEDICO, AVERBIS and the University of Würzburg, Chair of Artificial Intelligence and Knowledge Systems. The Next-GenTMF project develops and tests a digital solution – an eTMF – using artificial intelligence (AI) methods and technologies. Here, the AI identifies, indexes and classifies documents and document types with the help of Optical Character Recognition (OCR) and Natural Language Processing (NLP). This way, content correlations can be localised, and discrepancies, documentation gaps and suspected errors can be detected. iOMEDICO is a biomedical partner of the project. Our expertise and content (TMF, documents, audit reports, user experiences, etc.) from the application area of clinical trials support the development. We also analyse regulatory and user requirements and test and validate the application in the context of clinical trials. NextGenTMF is funded by the Federal Ministry of Education and Research in the KMU Innovativ (Information and Communication Technologies, ICT) programme and lasts 30 months.