The Journey from Passive to Active TMF with C.R. Bard, Inc. and Daiichi Sankyo

Manual systems are unable to keep up with the pace and volume of modern clinical trials, making it increasingly difficult for clinical operations teams to manage end-to end processes and information in clinical studies.

There are a variety of solutions being used by life sciences organizations to tackle this challenge. eTMFs are one of the most popular tools but these vary tremendously – from local or cloud file shares through to purpose-built eTMF applications.

The least mature solutions, such as local file systems, offer simple storage and archival of documents and are typically referred to as ‘passive’ TMFs. The most mature solutions are purpose-built eTMF applications, which actively manage TMF documents and processes and unify end-to-end processes in real-time as the TMF is being generated.

 Introducing the Veeva TMF Maturity Model

Veeva pioneered the TMF Maturity Model to evaluate TMF maturity levels of a life sciences organization. This framework and technique establishes and tracks maturity levels by asking respondents to answer a series of questions across nine different business categories – from strategy and infrastructure to compliance and governance.

 Hear how C.R. Bard, Inc and Daiichi Sankyo are optimizing their TMFs

As the industry continues its move from passive to active model, this webinar features two organizations who are currently on the journey to optimize their TMFs.

Since 2014, C.R. Bard has increased its TMF maturity score by two levels. The company selected Veeva Vault eTMF to aid the transition from a passive to active TMF operating model. The Vault eTMF structure is based on the DIA TMF Reference Model and this has enabled Bard to focus on standardizing across the whole clinical organization.

Hear from Bard’s Julia Lombardo on their road to maturity, the key areas for improvement, and their business goals for optimization.

Jamie Toth, from Daiichi Sankyo, will talk through her organization’s journey from legacy systems to a new, modern TMF approach. She will discuss how and why the company selected and implemented Vault eTMF, and how this has enhanced access, visibility, and control at their organization.

Jamie will share key learnings and benefits achieved along the TMF Maturity Model journey and discuss progress to future goals.

Speakers

Julia Lombardo, Clinical Applications Manager, C.R. Bard

Julia Lombardo has been with C.R. Bard Corporate Clinical for six years. She is currently Clinical Applications Manager at Bard. She was involved in the implementation of Veeva Vault eTMF and supports more than 150 Vault users globally. Julia holds a B.S. Computer Science degree from CUNY in Staten Island, NY. She started in the life sciences industry in 2002 as a data analyst for a contract research organization.

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Jamie Toth, Director and Head of TMF Operations, Daiichi Sankyo

Jamie Toth has more than 18 years of pharmaceutical IT experience. She joined Daiichi Sankyo last year after working at a CRO within the eTMF space. Jamie is a steering committee member for the DIA TMF Reference Model Working Group and is on the board for the Scientific Archivist Group (SAG) and the SAG-GCP executive board. She holds a Master’s degree in Clinical Research and Organizational Management from Drexel University, a Bachelor of Arts in Business Technology, and an Associates of Applied Sciences in Computer Systems and Technology.

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Jason Methia, VP, Vault Clinical, Enterprise, Veeva

Jason Methia serves as vice president for Vault and is responsible for growing and sustaining the market within the Enterprise market for Vault Clinical applications, including CTMS, eTMF, Study StartUp, and SiteExchange. Jason is focused on ensuring that Veeva delivers market-leading clinical business operations solutions and that Veeva customers are successful. He previously served as Veeva’s director for Vault eTMF strategy.

Prior to joining Veeva, Jason was the clinical documentation department head and TMF process owner at Vertex Pharmaceuticals. Jason was also the business owner for Vertex’s Study Startup Management System.

Jason has held a variety of roles ranging in clinical operations, regulatory affairs, and inspection readiness at organizations such as the Dana Farber Cancer Institute and Wyeth Research. He earned a bachelor’s degree in psychology from The University of Vermont and a master’s degree in regulatory affairs from Northeastern University.

 

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