PhlexTMF v21: Industry-First eTMF AI Reduces Risk of Document Misfiles and Metadata Errors

Improve TMF Quality and Inspection-Readiness While Reducing QC Burden

Industry Challenge: Higher Inspection Risk from Misfiled Documents TMF misfiles and metadata errors are an industry-wide problem, leading to poor-quality TMFs and time-consuming remediation to avoid the risk of inspection findings.

PhlexTMF offers the industry’s only next-generation eTMF AI that offers expert suggestions at the critical document upload step – reducing errors and improving TMF quality, completeness, and timeliness.

After users make their selection, PhlexTMF v21 then automatically populates the fields with the correct data – including Zone, Section, Artifact, Subartifact, Country, File Type, and more. Users unfamiliar with the TMF filing structure or who don't use the system often can file documents more quickly and accurately - while even highly trained users can save valuable time.

Features

• Delivers guidance of hundreds of TMF experts at the document upload step, helping prevent the risk of TMF document misfiles and metadata errors before they occur
• Reduces queries and time-consuming remediation, lowering costs and freeing up busy study teams
• Pre-trained on millions of TMF documents and effective on Day One – does not require diverting valuable study resources for training on your own documents
• Improves TMF quality, completeness, timeliness, and inspection-readiness