Interdisciplinary AI project NextGenTMF successfully completed

6. April 2025

The AI project “NextGenTMF,” funded by the German Federal Ministry of Education and Research (BMFTR), has developed convincing solutions in the field of clinical trial digitization. The project team, comprising experts from the University of Würzburg, Averbis GmbH, DHC GmbH, and iOMEDICO, set itself the challenge of digitizing handwritten study documentation in a time-saving and error-free manner.
All documents in the Trial Master File (TMF) of a clinical trial must provide a complete and traceable record of the trial. iOMEDICO contributed its more than 25 years of in-depth experience in conducting clinical trials to the project with a Master TMF. The digitization of this central document requires the transfer of a large number of forms, some with handwritten additions, into digital form, which is time-consuming and error-prone.

The BMFTR project incorporated technologies such as optical character recognition and handwritten text recognition, as well as various large language models. These different methodological approaches were developed between March 2022 and April 2024 and tested experimentally using a prototype.

The interdisciplinary team was able to show that the automatic transcription of eTMF documents with handwritten content leads to significant time savings while reducing errors. The research results have been submitted for publication.