Phlexglobal Announces Industry-First eTMF AI that Reduces Risk of Document Misfiles and Metadata Errors to Improve TMF Quality and Inspection-Readiness

Next-Generation eTMF AI the industry’s only solution ready on Day One to help organizations reduce the widespread risk of poor-quality and incomplete Trial Master Files

TMF Summit, West Palm Beach, FL — March 20, 2023 — Phlexglobal, a PharmaLex company and the recognized global authority in Trial Master File services and technology, today announced the general availability of PhlexTMF v21: the industry’s only purpose-built eTMF solution with next-generation artificial intelligence that helps ensure clinical documents are “right-first-time” at the critical document upload step. Organizations can utilize PhlexTMF v21 to significantly reduce TMF document misfiles and metadata errors – improving TMF quality, completeness, and timeliness, while freeing busy study teams from time-consuming queries and remediation effort.  

“Documentation misfiles and metadata errors continue to severely impact TMF quality across our industry, increasing inspection risk and adding an avoidable QC burden on overwhelmed staff,” noted Jim Nichols, Chief Product Officer for Phlexglobal. “Pre-trained on millions of TMF documents and embedding the cumulative guidance of hundreds of Phlexglobal’s TMF experts, PhlexTMF v21 allows companies to prevent many of these critical problems before they occur – immediately improving TMF management and inspection-readiness.” 

Every misfiled document can cascade into significant downstream impact and risk, since to an inspector the misfiled document does not officially exist and cannot be used in the eTMF to support the “story” of the trial. With TMF misfile rates approaching – and in some cases exceeding – 10% in some companies, PhlexTMF v21 helps prevent a single pebble from turning into an avalanche of risk. 

Unlike simple, first-generation TMF “bots” that require lengthy training on an organization’s own documents before delivering even limited value, Phlexglobal’s next-generation AI solution is ready to go on day one. Any life sciences organization, large or small, can obtain immediate value with the industry’s most complete and robust corpus of TMF document-handling algorithms. 

As a result, PhlexTMF v21 immediately enables new as well as experienced document submitters to: 

• Improve TMF quality and reduce inspection risk  
• Increase the speed and accuracy of document submissions  
• Focus on bringing TMF best practices around quality, completeness, and timeliness into the process earlier 

“We’re pleased to offer this powerful, industry-first AI solution to help organizations improve TMF management and reduce their compliance risk,” added Nichols. “By building on the already extensive capabilities of Phlexglobal’s eTMF, such as embedded quality review, smart completeness checks, and event management, the new PhlexTMF v21 offers the industry’s most advanced eTMF to help any organization achieve optimum quality, completeness, and timeliness for their Trial Master File.”