Happy New Year! 2014 was full of an amazing array of projects in our group, with a heavy focus on Trial Master File and related systems and processes (eTMF, CTMS, Clinical Architecture, Risk-Based Monitoring, etc.). As we look ahead in 2015 and exciting projects in eTMF, eISF (electronic Investigator Site File), and Clinical Portal, we are continually thinking about how to ensure clients consider the full requirements of GCP compliance when leveraging the capabilities of the new technologies.
TMF Inspection Readiness Doesn't Have to Be Chaotic
In both the paper and electronic TMF environments, sponsors who have not achieved continual TMF inspection readiness still scramble to locate and organize content, orient personnel, and complete extensive inspection readiness checklists and drills under immense pressure with uncertain outcomes. With the right lens, TMF inspection preparation scrambles - risky, expensive, time consuming, and unnecessary - can become a thing of the past.
My colleague Karen McCarthy Schau and I will dig into this different approach on January 28, 2015 during our webinar, Achieving Continual TMF Inspection Readiness: a metaTMF Approach to Preparedness and Compliance. We will discuss TMF inspection trends and inspectors’ perspectives, cover the critical factors to achieving inspection readiness, review the impact of governance and metrics on compliance and efficiencies, and make sure you walk away with practical ideas to improve your metaTMF maturity and TMF Information Architecture.
What is metaTMF? A New Approach to TMF Inspection Readiness
By the way, if you’re asking - what is metaTMF - it’s our way of broadening the conversation beyond the confines of eTMF systems. We are big believers in the capabilities of eTMF systems, and know that the marketplace is filled with excellent tools. However, tools are only as good as the people who use them.
To deepen the perspective, we focus on metaTMF - a holistic picture of complete Trial Master File management and governance which covers the full TMF lifecycle, accounting for the needs and actions of all stakeholders (trial subjects, PIs, site personnel, IRBs, inspectors, sponsors, vendors, etc.). metaTMF defines the content and data required for continual inspection readiness, aligned to the people, the processes, and the tools required to achieve deep maturity in TMF compliance, efficiency and effectiveness.
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Fran joined Paragon Solutions in April 2012, and is currently Associate Director in the Clinical and Regulatory Optimization practice. She previously worked at Genzyme / Sanofi for more than a decade, and has more than 20 years of academic and industry clinical and process expertise. She presents frequently at industry conferences, and is a member of several industry initiatives, including TMF Reference Model, OASIS eTMF Interoperability, and ACRES.