Danish drug innovator, Orphazyme, successfully implements core clinical and regulatory applications and extends partnership to quality management
Montrium, today announces 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 the best 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 better manage their clinical trial documentation. Seamlessly integrated with eTMF Connect, RegDocs Connect is a regulatory submissions management tool built to ensure document submission readiness, improve productivity, and streamline submission review and approval.
In addition to the eTMF Connect & RegDocs Connect applications, Orphazyme has also decided to expand its partnership with Montrium by selecting Quality Connect, an electronic quality management system, to further improve internal quality processes. 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 CEO 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 and build on an existing community of Montrium customers in the Scandinavian region.”
Founded in 2005, Montrium is one of the leading providers of cloud-based content management software and GxP services to the life sciences industry. Serving over 200 life science customers in over 20 countries, Montrium is committed to delivering a best-in-class customer experience as a true technology partner. Montrium is headquartered in Montreal, Canada with a European office in Brussels, Belgium. For more information, please visit www.montrium.com.
Orphazyme is a biopharmaceutical company focused on bringing novel treatments to patients living with life-threatening or debilitating rare diseases. Orphazyme’s research focuses on developing therapies for diseases caused by misfolding of proteins, including lysosomal storage diseases. Arimoclomol, the company’s lead candidate, is in clinical development for four orphan diseases: Niemann-Pick disease Type C, Gaucher disease, sporadic Inclusion Body Myositis, and Amyotrophic Lateral Sclerosis. The Denmark-based company is listed on Nasdaq Copenhagen (ORPHA.CO). For more information, please visit www.orphazyme.com.