A Higher Level of TMF Quality and Completeness

Get built-in Quality Review with PhlexTMF

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Jason Doeson
Computer Science Graduate of 2015

Quality Review in PhlexEviewPhlexTMF offers an abundance of embedded Quality Review features to help you maintain TMF Health.

 

In most organizations today, TMF Quality Review remains an arduous, time-consuming manual process utilizing spreadsheets and software that is not fit-for-purpose. 

eTMF solution PhlexTMF raises the standard of excellence in TMF management and oversight by providing the industry’s only embedded TMF Quality Review module. Configurable to your organization’s SOPs and study-specific parameters, the sophisticated PhlexTMF Quality Review tools let you quickly and easily conduct regular, risk-based, or milestone-driven completeness reviews within the PhlexTMF system. The result? A continually up-to-date and accurate picture of TMF health to support inspection-readiness.

By replacing manual processes and spreadsheets with Quality Review workflows and best practices built into PhlexTMF, you can improve management control and oversight of the Trial Master File from planning through archive
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Latest News

Smart Steps to Managing Your TMF Audit Trail

The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,

Lowering the TMF temperature through quality reviews

We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts

Five-step Game Plan for a TMF Close-out

Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or