Elan Selects Medidata Rave(R) to Support Clinical Development Activities



    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.