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



    Industry Pioneers Combine Expertise to Deliver Insight on Critical
Strategies and Technologies for Enabling Adaptive Clinical Trials

    BETHESDA, MD., June 13 /CNW/ - 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.




For further information:

For further information: UBC Contact: United BioSource Corporation Tess
Drahzal, 240-644-0420 Tess.Drahzal@unitedbiosource.com or Medidata Contact:
Lois Paul & Partners Susan Lombardo, 781-782-5767 Susan_Lombardo@lpp.com or
Tessella Contact: Tessella Emily Turberville-Tully, +44(0)1235-555511
Emily.Turberville-Tully@tessella.com

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MEDIDATA SOLUTIONS WORLDWIDE

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