FOR IMMEDIATE RELEASE
Lundbeck Selects Medidata Rave® to Manage
Global Electronic Clinical Trials
Denmark-based Specialty Pharmaceutical Company Implements
Industry’s Leading EDC Solution for Phase II–IV Studies
NEW YORK, NY – August 16, 2007 – Medidata Solutions today announced that H. Lundbeck A/S has chosen to implement Medidata Rave 5.6 as its electronic data capture (EDC), management and reporting solution. An international pharmaceutical company focused on treatments for psychiatric and neurological disorders, Lundbeck plans to use Medidata Rave to manage several Phase II–IV trials in the coming months, with the goal of conducting 10 or more studies in Rave each year. Lundbeck’s first study in Medidata Rave 5.6 will launch in September 2007.
Founded in 1915, Lundbeck maintains a strategic focus on developing therapies for central nervous system (CNS) disorders, including depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. Lundbeck had been using EDC for a few years, but as its clinical needs evolved, the company sought a modern system that would enable critical user functionality and scalability to handle larger, multi-national studies. The company opened its search for a user-friendly EDC system that would streamline studies and allow timely access to higher quality data. After completing an extensive evaluation of the industry’s leading EDC solutions, Lundbeck narrowed its search to Medidata and one other software provider. The company chose Medidata Rave as the system that was strongly favored by CRAs and site managers and was able to meet Lundbeck’s evolving clinical needs.
According to Lundbeck’s EDC Team Leader Medidata Rave offered several key benefits over competing systems:
The software’s modern architecture and intuitive, clean interface made it extremely easy for CRAs and site managers to learn.
Lundbeck’s IT executives were impressed with Rave’s ability to maintain optimal speed and performance.
By leveraging Rave’s Global Library, Lundbeck will speed the design of multiple studies by enabling study designers to easily select and reuse components ranging from edit checks to entire forms and visit structures.
Rave’s Amendment Manager now allows Lundbeck’s study team to easily incorporate protocol amendments to on-going studies, including migrating previously entered data without system downtime.
Because Rave also works on any computer and is browser-independent, Lundbeck is able to reduce costs around the provisioning and maintenance of laptops at sites.
Lundbeck’s head of ICR System Support sees Medidata Rave as a critical building block that will play a central role in the company’s clinical processes. With the ability to easily integrate with other systems, Lundbeck expects to achieve access to clinical and operational data that will enable earlier decision-making throughout each trial.
“More and more, Medidata Rave is serving as the ‘backbone’ of the clinical research process—and we are pleased Lundbeck will benefit from Rave’s ability to easily integrate with other systems, meet the requirements of both large-and-small scale studies and enable them to rapidly conduct multiple studies in their strategic area of research,” said Tarek Sherif, CEO of Medidata Solutions. “We greatly look forward to a long-standing relationship with Lundbeck and helping to streamline the development of novel CNS therapies that will make a significant difference in the lives of patients around the world.”
About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data—the lifeblood of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market—on six continents and in more than 80 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com.
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