Phlexglobal TMF Heatmaps provide a detailed visual and textual roadmap to improving TMF health and inspection-readiness
Executive Analysis: The Phlexglobal TMF Heatmaps executive summary offers a visual and textual overview of the key TMF quality and completeness findings from an inspection standpoint, identifying recurring patterns and pinpointing major and minor areas that need to be addressed. With this executive overview, you will be better equipped to prioritize your efforts and resources on the most important findings, and also gain a valuable tool to effectively communicate and justify important actions to management and other functional areas.
Actionable Insights: The solution gives you a detailed and easy-to-follow roadmap regarding the key actions your organization should take to improve TMF health and inspection-readiness. Visual heatmaps derived from the information in your eTMF help pinpoint key problem areas according to different criteria such as site, trial, country, or service provider – with the ability to further drill down to uncover the source of any issues.
Expert Guidance: Following the analysis of the Heatmaps findings, Phlexglobal can provide an updated recommendation of how to proceed, potentially adjusting the QC approach and offer practical suggestions based on years of experience conducting clinical trials and managing Trial Master Files.
The Shoulds and Shouldn’ts of Electronic Systems and Data in Clinical Trials Intro With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618
Trial master file misfiles are a common occurrence, with as many as one in every 10 documents being misfiled. In some ways, misfiles are an even greater issue now with eTMF systems, where filing is
Introduction Well, first and foremost, welcome! Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those