Pharmaceutics research firm is helping its teams better manage their clinical trial documentation
Biotechnology and pharmaceutical contract research organisation Altasciences has chosen Montrium’s electronic trial master file (eTMF) Connect to improve compliance. It will use the solution to help its teams better manage their clinical trial documentation and enhance collaboration with a centralised interface.
eTMF Connect is part of a suite of applications that make up Montrium’s Connect Platform, an electronic content management platform that supports life science organisations.
“With over 250 ongoing 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.”
The move from a paper-based TMF process to an electronic system offers Altasciences’ teams real-time reporting features using the eTMF Navigator dashboard. Sponsors can also access their documentation in real time, providing them with direct oversight of the TMF.
“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 organisations in their rapid growth,” said Oliver Pearce, director of Commercialisation at Montrium. “From our first discussion it was clear that both organisations shared the same values around transparency, quality and innovation – partnering together to advance early phase research was an obvious next step.”