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IT vendor offers a service to measure TMF capabilities
Where do pharma companies stand regarding their use of automated systems for monitoring trial master files (TMFs), the documentation collected during a clinical trial? Veeva Systems’ (Pleasanton, CA) service offers some objective measures of how research organizations are managing the process, according to Jason Methia, director of Vault eTMF strategy at the company. TMFs are set alongside a clinical trial management system (CTMS) at many trial sponsors and contract research organizations (CROs), but many are still paper-based or managed off of spreadsheets or home-grown, nonstandard systems. (There is a TMF Reference Model, developed by a project team of the Drug Information Assn.; version 3 was published last June.)
Veeva’s maturity model ranks TMF development on a 1-5 scale; broadly speaking, from completely manual to completely electronic (eTMF). A key value of eTMFs, says Methia, is the ability to establish an audit trail for changes in trial progress and record-keeping. Regulatory agencies like FDA or the UK’s MHRA periodically conduct audits of the TMF when an application for drug approval is presented to them,” notes Methia. “A compilation performed by MHRA in 2014 found that 35% of TMFs had auditability problems.” He says that, based on surveys and studies performed by Veeva, most pharma companies rate around 2.54 on the 1-5 scale. At an average of level 3 and above, TMFs are being actively managed, with draft documents being checked in and out of the systems, electronic signatures appended to files and other aspects of an electronically based system, he says.
Veeva, a leader in cloud-based IT systems for life sciences, set up its Vault platform for storing various types of documents in a secure, trackable manner, and developed Veeva Clinical (of which its eTMF product is a part) in 2012. The cloud-based aspect allows for ease of access for trial sponsors, CROs and investigators sites and according to recent customer surveys, the volume of paper being handled is being reduced by a third to half currently, with more improvements ahead. The Veeva eTMF is said to fully support the DIA TMF Reference Model.
Access to the eTMF Maturity Model, which can be evaluated in a self-service mode, is here.