United BioSource Corporation, Medidata Solutions and Tessella to Present Webinar Series on Adaptive Clinical Trials



    United BioSource Corporation (UBC), Medidata Solutions and
    Tessella today announced the first in a series of six educational
    webinars on adaptive clinical trials. The webinar series, entitled
    "Enabling Adaptive Clinical Trials," will bring together key players
    from sponsors, services providers and regulatory authorities to
    provide real-life solutions to the complexities of planning and
    executing an adaptively designed clinical trial.

    Successful execution of an adaptive clinical trial requires
    sponsors to change processes, implement technologies and apply
    strategic clinical expertise and scientific knowledge in entirely new
    ways. In these webinars, UBC, Medidata and Tessella will reveal the
    critical requirements and functions necessary to make an adaptively
    designed clinical trial an operational reality. Each company brings
    essential experience in key areas:

    -- Tessella - Adaptive trials implementation services and
    award-winning enablement tools;

    -- UBC - Trial design, investigator training, interactive
    voice/web response (IVR/IWR) technology solutions, and data
    management;

    -- Medidata - Electronic data capture (EDC), management and
    reporting technology solutions.

    "With the anticipated increase in regulatory acceptance, adaptive
    trial designs are at the forefront of drug development and offer
    sponsors the potential to shorten timelines, decrease costs and most
    importantly, improve patient safety," said Tom Parke, Tessella's Head
    of Clinical Trial Solutions. "While the benefits are potentially huge,
    adaptive clinical trials are still a challenge, and few have
    determined exactly how to implement them successfully."

    The first webinar, entitled "Operational Challenges and Strategic
    Planning," will be held on July 11th. Participants can register at
    www.enablingadaptivetrials.com. This installment will discuss the
    business and regulatory factors accelerating the adoption of adaptive
    clinical trial designs. Participants will learn about the benefits
    associated with well-planned adaptive clinical trials when process,
    technology and know-how are successfully applied.

    "A seamless transactional backbone - one that integrates trial
    simulations, EDC, clinical data management system (CDMS), IVRS/IWRS,
    electronic patient reported outcomes (ePRO), drug supply and the
    adaptive algorithm - provides a foundation on which adaptive clinical
    trials can be executed and scaled across an organization," said Dr.
    Hugh Levaux, Medidata's Vice President of Product Strategy. "Real-time
    information for decision-making and dynamic linking of operational and
    clinical data allows sponsors to quickly implement modifications in
    study design."

    "Even with the right regulatory environment and the right
    technology, sponsors who are looking to execute adaptive clinical
    trials need to devote time to planning for this change to the clinical
    process," said Michael Borkowski, General Manager of Clinical
    Technologies at UBC. "By understanding how to prepare for this
    multi-disciplinary approach, sponsors will be able to fundamentally
    improve their processes and thereby realize the ROI adaptive trials
    can bring."

    Future installments of "Enabling Adaptive Clinical Trials" webinar
    series will be announced in the coming weeks.

    About UBC

    UBC is a global pharmaceutical services organization that combines
    deep scientific knowledge with broad execution expertise across the
    lifecycle continuum. Our focus is on generating real-world data to
    support the development and commercialization of medical products for
    emerging and established life science companies. We partner with our
    clients to offer services in scientific research and consulting, late
    stage development, post-approval registries and drug safety, data
    integration, clinical technologies, investigator services, patient
    recruiting and education. For more information, please visit
    www.unitedbiosource.com.

    About Tessella

    Since 1998, Tessella has been helping to drive innovation in drug
    development by enabling the deployment of Bayesian-based adaptive
    clinical trials. Tessella has implemented statistical models for phase
    1 trials, phase 2 dose finding studies using Bayesian statistics, and
    phase 2/3 seamless designs. Tessella has supported these models by
    developing simulation and analysis tools, and by building and running
    the infrastructure to run the trials. For more information, please
    visit www.tessella.com/adaptivedesigns.

    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.