Altasciences Drives Inspection Readiness and Sponsor Oversight with eTMF Connect Platform
Montrium, a cloud-based SaaS solutions and GxP services for the life sciences, shared that Altasciences has implemented their eTMF Connect platform to support their drive for scientific excellence in early-phase clinical studies.
A contract research organization supporting drug development for pharmaceutical and biotech sponsors, Altasciences now benefits from a dynamic, robust electronic Trial Master File platform.eTMF Connect, Montrium’s eTMF solution, helps teams better manage their clinical trial documentation and provides a centralized interface for effective collaboration.
“With over 250 on-going studies across the United States and Canada each year, we needed a powerful platform to keep up with changing technology and process expectations from both sponsors and regulatory agencies,” said Beth Williams, Associate Director of Project Management at Altasciences, “We are thrilled to have more consistency in TMF management and visibility into the health of our trial master files. With eTMF Connect, we’ve increased compliance and oversight to maintain inspection readiness both for Altasciences and our sponsors.”
Moving from a paper-based TMF process into an electronic system allows Altasciences teams to benefit from real-time reporting features using the eTMF Navigator dashboard. Externally, sponsors have the same real-time access to their documentation allowing direct oversight of the TMF without the need for manual requests.
“Partnering with a research powerhouse like Altasciences is a key milestone for the Montrium team and is a reflection of our focus on helping emerging organizations in their rapid growth,” said Oliver Pearce, Director of Commercialization at Montrium, “From our first discussion it was clear that both organizations shared the same values around transparency, quality and innovation – partnering together to advance early phase research was an obvious next step.”
eTMF Connect is part of a suite of applications that make up the Connect platform, an electronic content management platform supporting life science organizations.
For more information please visit www.montrium.comand www.altasciences.com
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