Machine Learning In The eTMF: Human-Aided Active Learning Processes

By Jay Smith, Head of Product, Trial Interactive

Every day we get closer to being able to automate the document processing and administration that consumes so many hours and can distract from treatment and research. As we can all attest, clinical trials are among the largest administrative endeavors in the wide world of business operations, so we should have every reason to be enthusiastic about any technology that can reduce this effort while improving quality.

The trial master file (TMF) is a focus of at least some of this excitement. The TMF is one of several places where a lot of manual effort is required for the collection and classification of the documentation used to ensure GCP compliance. This effort is a time-consuming back-office requirement that is necessary for regulatory compliance during clinical research.

This article reviews the potential advantages of artificial intelligence and machine learning as well as obstacles that need to be overcome.