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.
