Medidata Solutions, a global provider of electronic clinical data
capture, management and reporting solutions, today announced that
Medidata Rave(R) has been selected by ViroPharma Incorporated as its
enterprise-wide e-clinical platform. After an extensive 10-vendor
review process, ViroPharma chose Medidata Rave for the collection and
management of clinical data for all global Phase I-III studies in the
U.S., Sweden, Canada, Germany, Belgium and France.
With a focus on the development and commercialization of products
used by physician specialists in hospital settings to treat serious
diseases, ViroPharma is recognized worldwide for the advancement of
innovative products addressing unmet medical needs. Because ViroPharma
conducts trials throughout North America and Europe, the company
needed a clinical data management solution that could scale globally,
while allowing investigators and monitors to manage and view data in
real-time. ViroPharma also required a solution that would provide ease
of study build and deployment with intuitive navigation for
investigators worldwide.
While ViroPharma had piloted electronic data capture (EDC)
solutions for several years, in September 2005 the company began an
evaluation of EDC vendors in order to standardize on one solution.
After an initial review of proposals, six vendors underwent technical
evaluations. From this group, ViroPharma selected four vendors to
complete on-site evaluations.
"In the end, we chose Medidata Rave as our standard because it
best meets our needs through features such as a user-friendly
interface and robust data management. We were also impressed with the
clinical and technical expertise of Medidata's professional services
personnel," said Patty Wolf, clinical data manager at ViroPharma.
"Medidata Rave allows us to operate very efficiently with our clinical
teams, and its ability to integrate with other applications should
facilitate future improvements to our clinical trial processes."
ViroPharma has implemented Medidata Rave for 15 trials to date and
has forecasted its role in additional trials in 2007. Unlike other
platforms, Rave allows users to work in different countries against a
single, global, centrally-managed repository of clinical data -
allowing for real-time electronic access of trial data. For
investigators, this means reduced time entering in the case book per
patient due to automatic query generation, and requires less storage
space than paper case report forms.
"ViroPharma's selection of Medidata Rave from a group of 10
vendors speaks to the industry-leading ease of use, flexibility and
completeness of our solution for investigators, monitors and data
managers within any phase of a clinical trial," said Tarek Sherif, CEO
of Medidata Solutions. "The selection of Medidata Rave as ViroPharma's
standard for clinical trials management demonstrates our ability to
scale our product and services to meet the needs of a global client.
We look forward to working with ViroPharma as they continue to
increase the value of their clinical research investments."
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated
to the development and commercialization of products that address
serious diseases treated by physician specialists and in hospital
settings. ViroPharma commercializes Vancocin(R), approved for oral
administration for treatment of antibiotic-associated pseudomembranous
colitis caused by Clostridium difficile and enterocolitis caused by
Staphylococcus aureus, including methicillin- resistant strains (for
prescribing information, please download the package insert at
http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently
focuses its drug development activities in viral diseases including
cytomegalovirus (CMV) and hepatitis C (HCV). For more information on
ViroPharma, visit the company's website at http://www.viropharma.com.
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 five continents and in more than 70
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.
