Case Study

AI-Assisted Indexing Improves TMF Management

AI Files document processing iStock-1163245440

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.

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