Medidata Solutions Shapes Conference Agenda at 43rd Annual DIA Meeting

    Key Executives to Present and Chair Conference Sessions on Adaptive
Clinical Trials and Regulatory Issues

    NEW YORK, June 11 /CNW/ - Medidata Solutions executives will discuss key
issues in presentations at the 43rd Annual DIA Meeting, to be held on June
17-21, 2007, at the Georgia World Congress center in Atlanta, Ga. Medidata
presentations will focus on today's e-clinical environment, from auditing and
adaptive clinical trials to regulatory issues and validation. In booth #1327
at this year's meeting, the Company will showcase Medidata Rave(R), the
industry-leading electronic data capture, management and reporting solution.
Joining Medidata will be key technology partners to demonstrate how Rave,
integrated with partner applications, meets a range of clinical data
management needs. Medidata executives will be available to discuss Rave's role
in dynamically linking clinical and operational data.

    Medidata's co-founder and Chief Technology Officer Glen de Vries and Vice
President of Global Regulatory Affairs and Quality Assurance Earl Hulihan will
be participating in the following sessions:

    "Assessing and Auditing Clinical Computerized Systems"

    Session Chair: Earl Hulihan, VP of Global Regulatory Affairs & Quality

    Validation Track: Wednesday, June 20, at 8:30 a.m. ET, Room A311

    As session chair, Hulihan will lead a discussion on the key requirements
needed for computer system validation to demonstrate data integrity and meet
regulatory and industry best practices. Clinical research experts from
Northeast Clinical Research Center, ICON Clinical Research and the Lehigh
Valley Health Network will join Hulihan in this session.

    "The Role of Electronic Data Capture in Adaptive Clinical Trials"

    Session Chair: Glen de Vries, Co-founder & Chief Technology Officer

    eClinical Track: Wednesday, June 20, 10:30 a.m. ET, Room A314

    Jerry Schindler, DrPH, Vice President, Late-Stage Clinical Development
Statistics at Merck & Co., and Michael Borkowski, General Manager of the
clinical technologies group at United BioSource Corporation, will join de
Vries to discuss the operational challenges of adaptive clinical trials by
defining the requirements and processes for successfully implementing adaptive
clinical trials through the use of EDC.

    "The Process Taken and Likely Outcome from Red Apple II"

    Speaker: Earl Hulihan, VP of Global Regulatory Affairs & Quality

    Validation Track: Thursday, June 21, 8:30 a.m. ET, Room A313

    As co-chair of The Red Apple II team of international participants from
the academic and government industries, Hulihan will discuss how the team
created and implemented the "Computerized Data Systems for Nonclinical Safety
Assessment: Current Concepts and Quality Assurance" standard in 1987. After it
was published by the DIA, it stood as the de facto standard for over 20 years.
Hulihan will also address how the team updated original material to reflect
the current environment and the new challenges confronting non-clinical

    "Presenting Your Investigational Site's Use of EDC: Best Practices"

    Speaker: Earl Hulihan, VP of Global Regulatory Affairs & Quality

    GCP Track: Thursday, June 21, 10:30 a.m. ET, Room B405

    During this presentation, Hulihan will draw on his extensive experience
as a clinical investigator to provide practical advice on how to prepare site
staff for the unique challenges posed in hosting an audit in an EDC
environment. Through a discussion of real-life examples and focused
strategies, attendees will learn the tactics needed to conduct an audit with a
successful outcome.

    For background information on Medidata executives, please visit

    About the Drug Information Association (DIA)

    The Drug Information Association serves more than 25,000 professionals in
the biotechnology, pharmaceutical and regulatory industries worldwide. Through
its domestic and international meetings, training courses, workshops and
webinars, DIA provides a neutral global forum for the exchange of information
critical to the advancement of the drug discovery and lifecycle management
processes. Headquartered in Horsham, Pa., USA, and with offices in Basel,
Switzerland and Tokyo, Japan, the association is led by its volunteer-based
board of directors and executive management team. For more information, visit or call 215.442.6100.

    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

For further information:

For further information: Lois Paul & Partners Susan Lombardo,

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