Medidata Solutions to Address Regulatory Initiatives, Adverse Events and Patient Reported Outcomes at November Industry Conferences



    Company Executives to Drive Discussions at DIA Outsourcing Summit, Canada
Annual Public Health Days and CBI's Premier Conference on Patient Reported
Outcomes

    NEW YORK, November 5 /CNW/ - Executives at Medidata Solutions, a global
provider of electronic clinical data capture, management and reporting
solutions, will present at four leading industry conferences this month:

    
        DIA Winning Strategies for Achieving a Quality EDC Clinical Trial
         Process
        November 13-14, 2007 Weston, Florida
        Chair: Frances Nolan, Vice President, Global Quality Assurance
        Session Title: "Data Output, Reporting, and Analysis in EDC
         Clinical Trials"
        Date & Time: November 14 at 10:30 a.m.

        Speaker: Keith Howells, Vice President, Development
        Session Title: "A Generic Approach to Producing Analysis Datasets
         from EDC"
        Date & Time: November 14 at 10:30 a.m.

        This conference will provide sponsors, CROs, investigational
         sites, IRB members and EDC and electronic health records (EHRs)
         companies with the opportunity to discuss and propose process
         changes, assessment/audit methods and delivery practices for
         assuring the quality of electronically captured data across the
         whole chain of clinical trial activities. Chair of the panel,
         Nolan, along with featured presenter Howells, will drive
         discussion on addressing the opportunities and challenges
         associated with data output, reporting and analysis in EDC-based
         clinical trials. Attendees will also gain insight into the
         advantage offered with EDC in its ability to process and report
         data in real-time.

        DIA Outsourcing Summit
        November 13-14, 2007 Weston, Florida
        Speaker: Frances Nolan, Vice President, Global Quality Assurance
        Session Title: "Effective OS: Lessons for Successful Partner
         Selection"
        Date & Time: November 13 at 10:30 a.m.

        The DIA Outsourcing Summit will bring together executives and
         operational personnel to benchmark best practices and engage in
         discussions on how to achieve greater value from outsourcing. As
         a member of a panel discussion detailing sponsor- provider
         relationship management, Nolan will highlight recommendations for
         choosing partners to fit the needs of a company's organization
         and study.

        Annual Public Health Days
        November 20-23, 2007, Montreal, Canada
        Speaker: Dr. Barton Cobert, Vice President, Global Regulatory
         Initiatives & Pharmacovigilance
        Session Title: "What Can We Expect from the Health Authorities and
         Drug Companies to Protect the Public from Drug Adverse Events
         Seen with New Products?"
        Date & Time: November 22 at 10:00 a.m.

        This year's conference theme, "Building on Concrete Evidence,"
         underlines the importance for public health to base its actions
         on solid data - and program evaluation is at the core of these
         concerns. In Cobert's session, attendees from Canada, Brazil and
         the US will learn about the issue of access to medicines and
         health care in a globalized world.

        CBI's Premier Conference on Patient Reported Outcomes
        November 28-29, 2007, Washington, D.C.
        Speaker: Hugh P. Levaux, Ph.D., Vice President, Product Strategy
        Session Title: "Interpret FDA's Draft Guidance on PRO and
         Proactively Prepare for Upcoming Changes"
        Date & Time: November 28 at 1:30 p.m.

        As patient reported outcomes (PRO) are becoming an essential
         component of clinical research, it is more important than ever
         before to remain on the cutting edge of technology and regulatory
         strategy. This conference will bring together professionals
         impacted by this change to share insights and best practices.
         During his session, Levaux and co-presenter Jean Paty, vice
         president of scientific, quality and regulatory affairs at
         invivodata, will discuss sections of the guidance that address
         switching from PRO to ePRO as well as integrations of PRO data
         with EDC data.
    

    For background information about Medidata executives, please visit
http://www.mdsol.com/about/team.htm.

    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: Lois Paul & Partners Susan Lombardo,
781-782-5767 Susan_Lombardo@lpp.com

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