AI-Assisted Indexing Improves TMF Management

The timely and accurate filing and indexing of documents for the Trial Master File is one of the most significant compliance challenges facing organizations today. Requiring time-consuming and repetitive manual effort from highly trained professionals, this process is tailor-made for artificial intelligence to “take the robot out of the human.”

This case study examines the results achieved by a mid-sized biopharmaceutical company leveraging the industry-proven AI-assisted indexing capabilities within Phlexglobal’s PhlexTMF software. The advanced eTMF solution includes sophisticated machine learning algorithms purpose-built for life sciences, trained on more than one million real-world TMF documents.

The bottom line? The company significantly reduced manual document processing time and effort, with no reduction in quality – accelerating submission timelines while freeing staff for other critical projects.