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 TMFsAs 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.
Keywords: Clinical Trials, eTMF, Clinical Data