Horizon Pharma plc to Leverage Medidata Clinical Cloud® and eTMF Solutions to Support its Business Transformation

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Company News Release

NEW YORK & DUBLIN, October 26, 2017-(BUSINESS WIRE)-Medidata (NASDAQ: MDSO), a global provider of cloud-based solutions and data analytics for clinical research, announced that Horizon Pharma plc (NASDAQ: HZNP) has selected the Medidata Clinical Cloud® platform to meet its eTMF and Study Conduct requirements; as well as a full suite of solutions for their end-to-end clinical research needs. 

“Our primary goal has been to address our business needs, while streamlining multiple technologies for a more efficient, manageable, and cost effective clinical trial process.”

The Medidata Clinical Cloud makes it possible for the company to take advantage of a number of services for clinical research, all from one platform. This includes Medidata eTMF, a scalable regulated content management solution that will enable the company to centralize and streamline the management and archival of Trial Master File content, while also enhancing the value of its investment in the Medidata clinical trial management system (CTMS). 

To streamline its clinical research, Horizon will leverage Medidata Rave®, a solution for capturing, managing, and reporting patient data; and Medidata Balance®, which unifies randomization, trial supply management, and EDC into one system. Horizon will also standardize the timely collection and management of adverse events with Medidata Rave Safety Gateway® and accurately calculate and disburse on-time site payments with the Medidata Payments Cloud, all from the Medidata platform. 

“Our primary goal has been to address our business needs, while streamlining multiple technologies for a more efficient, manageable, and cost effective clinical trial process,” said Amy Grahn, Sr. Vice President, Clinical Development and Operations, Horizon Pharma plc. 

Additionally, as part of its collaboration with Medidata, Horizon will leverage Medidata Coder® to streamline and centralize medical coding; and Medidata TSDV and Medidata CSA, to enable prioritization of resources around key areas of risk, such as patient safety, data quality, and integrity. 

“We are in a unique position to provide the full clinical trial picture to our customers, all due to our rich and unified Medidata cloud platform,” said Mike Capone, chief operating officer at Medidata. “Medidata is removing complexity and inefficiencies in clinical trial research, enabling customers to meet regulatory requirements, more effectively manage data, and focus their full attention on making patient breakthroughs.” 



About Medidata 

Medidata is reinventing global drug and medical device development by creating cloud-based solutions for clinical research. Through our applications and data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including over 850 global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations. 

The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers-from study design and planning through execution, management, and reporting. 

About Horizon Pharma plc 

Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring, and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets 11 medicines through its orphan, rheumatology, and primary care business units. For more information, please visit www.horizonpharma.com.