Working to bring together disparate trials operating in silos around the globe, medical device giant C.R. Bard went from proof of concept to launching an active electronic trial master file (eTMF) operation in just over two years. It was an idea whose time had come, according to Julia Lombardo, clinical operations manager.
With more than 100 significant offices around the globe, Bard’s four U.S. divisions ran separate clinical trial operations, most of which were still paper-based in March 2015, when the new eTMF project was first getting off the ground.
Operating under a passive system, “it was very difficult to get an idea of how complete our TMF was,” Lombardo said. “In preparation for an audit, it was impossible to gather everything into one place.” She provided her case study on how Bard worked with Veeva’s Vault eTMF system at a webinar sponsored by Veeva, “Moving from Passive to Active TMF with the TMF Maturing Model.”
There are a number of important differences between passive and active TMF.
Passive TMF operations tend to be paper-based, often relying on document scanning. Study teams do not regularly access the TMF, which is also not integrated with other clinical systems. There are also zero or few manual key performance indicators (KPIs) or metrics.
By contrast, under active TMF operating models, documents are managed within the system. Sites, contract research organizations, and sponsors have eTMF access. The system is integrated with other eClinical systems. Real-time KPIs and metrics are used for active management.
By September 2017, Bard had 28 active studies in its eTMF vault, with more than 160 global users. It was leveraging real-time metrics for active management, and delivering training for legal and contracts personnel. In addition, TMF management was monitored.
Bard has seen a number of benefits right out of the gate, Lombardo said. For example, “we’ve put together custom formula fields to be able to collect the time it takes for a monitor to submit a report, [and] track how long it takes a reviewer to review the report and send it back.” Bard is comparing that data with internal SOPs that outline what the time period should be for these parts of the process. “We’re trying to see how long it actually takes, and where the gaps are,” Lombardo added.
Looking at another benefit, Bard trained staff who can now author New Drug Applications for submission to the U.S. Food and Drug Administration and clinical study agreements between the sponsor and study sites. While sites don’t have access to the Vault eTMF system and cannot do full electronic signature approvals, document control mean there’s “no more e-mailing different versions back and forth” between contract managers at the sponsor and sites, Lombardo said.
Author: Michael Causey