Denmark-based Specialty Pharmaceutical Company Implements Industry's
Leading EDC Solution for Phase II-IV Studies
NEW YORK, August 16 /CNW/ - 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
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.
For further information:
For further information: Lois Paul & Partners Susan Lombardo,