Managing the Trial Master FileAn eTMF Technology GuideTABLE OF CONTENTS Introduction Who Needs an eTMF, Anyway? The Regulatory Requirement for an eTMF The Critical Role of an eTMF Three Generations of eTMF Systems The Need for a New Generation of eTMF Ten Defining...
Enlivex Therapeutics Adopts Agatha to Manage eTMFEnlivex adopted Agatha Clinical (eTMF) to help improve the management of its trial master file. Enlivex is a clinical-stage company focused on specialized cell immunotherapy, we intend to develop and commercialize an...
Webinar On Demand: 5 Steps to TMF Inspection ReadinessThe Five Steps to TMF “Inspection Readiness” explores the real meaning of being inspection-ready and demonstrates why that goal is impossible without a more modern plan. Janine Penman, a clinical operations...
Clinical Operations as a distinct corporate function and department has evolved into a standard corporate model at sponsor and CRO companies, with all the trappings: Titles (e.g. Director of ClinOps), standard roles, its own language, a bevy of software...
With so many eTMF solutions available today, how do you know which one is right for you? Many of these solutions provide similar features and functionality but there are ten requirements of a modern eTMF solution that you need to look for. And we're providing them...
Webinar On Demand: A Site Assessment Tool for Remote MonitoringAgatha sponsored the Proactive GCP Compliance Conference. Many dropped by our virtual booth for a chat about ClinOps technology, including TMF, Remote Monitoring, Quality, and Regulatory compliance.This...
Webinar On Demand: 5 Tell Tale Signs You are Ready for an eTMFLearn the five indicators that clearly signal your organization is not only ready for an eTMF but needs an eTMF to continue to conduct studies effectively. You will hear how other companies have analyzed...
You're having trouble managing the trial master file for your clinical trial. But how do you know if you need an electronic master file (eTMF) solution to help? It may seem like a simple answer, and maybe it is - if you’re looking at the right things. Here are five...
There is a lot of discussion about taking ownership of the trial master file (TMF). We wanted to understand what was behind this thinking of sponsors bringing the TMF in-house, so we reached out to an industry maven, Janine Penman of JPScientific, to fill us in. Who...
An Ode to the eTMF. Sonnet 43, Revisited. Oh, eTMF, how do you save me? Let me count the ways. When I extol the virtues of an eTMF application, I am sometimes asked to be more specific and more quantitative. When I say confidently that an electronic Trial Master...