Medidata Solutions today announced that Elan Pharmaceuticals, Inc.
has selected Medidata Rave as its electronic data capture (EDC),
management and reporting solution. Elan plans to begin using Rave in
mid- and late-stage clinical studies in North America.
Elan had limited previous experience using EDC and conducted
mainly paper-based trials. After a careful evaluation of the market
landscape, Elan´s management team identified EDC as a critical
component in clinical research and began looking for an EDC solution
that could address two major concerns. First, the product had to
easily integrate the data collected in an EDC system with other
systems across the company, as well as systems used by external
vendors and partners. Second, because much of Elan´s data management
is outsourced, the company needed a solution that could be readily
adopted by a contract research organization (CRO) without prior
experience with the technology.
Elan ultimately selected Medidata as its EDC provider from a field
of competitors, and by fully integrating Medidata Rave across Elan´s
systems and clinical processes, the company expects to achieve greater
access to clinical and operational data that will enable earlier
decision-making throughout each trial.
Medidata Rave offers several key benefits:
-- A robust architecture that would easily integrate with their
existing systems in order to securely and efficiently share
data;
-- High acceptance by investigators;
-- An easy learning curve, making the implementation of an
additional data system non-disruptive to researchers;
-- Instant access to clinical data, making it easier to predict
and prioritize monitoring efforts to make site visits more
effective;
-- Intuitive case report forms (CRFs) that may help Elan data
managers to reduce "petty queries," keeping studies on time
more often;
-- The ability to access data in real time, allowing monitors to
catch and respond to problems as early as possible.
"Each customer´s clinical requirements differ, and Medidata is
unique in our ability to critically evaluate the technical and
clinical needs of researchers to understand how Rave can properly
complement existing systems and enhance the experience of each
individual customer," said Tarek Sherif, CEO of Medidata Solutions.
"Medidata is proud to work with Elan as it moves toward its goal of
delivering promising therapeutics as safely and effectively possible
to serve patients and the health care providers caring for them."
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.
