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Applied Clinical Trials
Montrium has announced that Orphazyme, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, has chosen to extend Montrium’s eTMF Connect and RegDocs Connect solutions with Quality Connect to empower end-to-end commercialization processes.
With a growing team and potential for several registration studies occurring in the near-future, managing critical regulated content is a key priority for Orphazyme’s clinical teams. After determining a cloud-based system would bring unique benefits, Orphazyme’s team completed a thorough assessment of solutions on the market and selected Montrium as their strategic partner.
Montrium’s eTMF Connect application is a modern electronic Trial Master File solution that has been designed specifically for life sciences organizations to manage their clinical trial documentation. Seamlessly connected with eTMF Connect, RegDocs Connect is a regulatory submissions management tool.
In addition to the eTMF Connect & Reg Docs Connect applications, Orphazyme has also decided to expand its partnership with Montrium by selecting Quality Connect, an electronic quality management system. By leveraging Montrium’s Connect platform, Orphazyme has unified clinical, regulatory and quality activities in the cloud to modernize their core business processes.
Paul Fenton, Montrium’s Chief Executive Officer, shares, “When sponsors bring on a new software vendor like Montrium, it’s as if they bring on an extension to their team. We’re incredibly excited about partnering with such a well-established organization like Orphazyme to help them achieve their commercial goals as well as building on an existing community of Montrium customers in the Scandinavian region.”