US-based clinical life science solutions provider Bioclinica has announced the addition of a new, web-based module, electronic trial master file (eTMF) as part of its clinical trial management system (CTMS) offering.
The new eTMF offers a safe and secure storage location for document files related to clinical trials that are being tracked within Bioclinica CTMS by using the already linked SharePoint environment.
It will enable users to have direct control over all Bioclinica CTMS, eTMF, as well as ‘Site Monitoring/Payment’ functionality.
Bioclinica senior product manager Jeremiah Rehm said: “We are thrilled to make this functionality available as part of our CTMS solution.
“Organisations now have the choice to purchase a single solution or leverage our existing capabilities to integrate with other systems or data sources.”
eTMF module provides benefits such as utilising existing functionality already available within the linked SharePoint document libraries and supporting the DIA reference model.
It also ensures a regulatory compliance by offering a full audit trail, version history, and activity log for each file of the tracked document.
Furthermore, the module supports a role-based permission model.
Bioclinica Software Solutions president Guy Crossley said: “The addition of eTMF to our CTMS solution is a transformational change for the industry.
“Companies of all sizes are now able to take advantage of an integrated solution that eliminates redundancies, improves workflows, enhances transparency, and enables greater study control. And the system can be fully operational within only a few weeks, which is critical for any successful CTMS implementation.”
Last week, Bioclinica expanded its portfolio of specialty software solutions with the addition of ‘Image Redact AI’ for clinical trials.