Empresas y finanzas

Medidata Solutions Expands Management Team with Key Appointments in Safety and Quality Assurance



    Medidata Solutions, a global provider of electronic clinical data
    capture, management and reporting solutions, today announced the
    expansion of its senior management team with the appointments of Dr.
    Barton Cobert as Vice President of Global Regulatory Initiatives and
    Pharmacovigilance, Frances Nolan as Vice President of Global Quality
    Assurance and Dr. Tony Hewer as Senior Director of Global Quality
    Assurance for EMEA. These three executives bring a range of clinical
    development expertise to the Medidata group headed by Earl Hulihan,
    Vice President of Global Regulatory Affairs and Quality Assurance.

    "The pharmaceutical, biotech and medical device industries have
    always adhered to the highest standards of safety and quality
    assurance, and we have made very strategic choices in our selection of
    the executives who will drive these key areas," said Tarek Sherif,
    Co-founder and CEO at Medidata Solutions. "Each of these three
    executives brings critical pieces of expertise and experience in the
    clinical arena that will support Medidata's growth into new global
    markets while ensuring customers' adherence to industry standards and
    regulations."

    Dr. Barton Cobert, Vice President, Global Regulatory Initiatives &
    Pharmacovigilance

    As Vice President of Global Regulatory Initiatives and
    Pharmacovigilance, Cobert is responsible for interactions with
    regulatory agencies, oversight of Medidata's quality processes,
    knowledge and understanding of local and international regulations and
    company visibility in the international arena. Cobert has more than 20
    years of pharmaceutical industry experience, specializing in product
    safety and pharmacovigilance. He most recently served as global head
    of drug safety and pharmacovigilance at Novartis' Consumer Health
    Division, where he was responsible for worldwide drug, device,
    cosmetic, nutritional supplement and adverse event reporting. He also
    has held various management positions in pharmacovigilance, medical
    research, medical safety and services at Hoechst-Roussel,
    Schering-Plough, Forest Research Institute and Becton Dickinson.
    Cobert received his M.D. from New York University in 1974 and served
    as a physician in a range of hospitals in both the U.S. and Europe. A
    frequent contributor to industry and medical journals, Cobert has also
    written two textbooks on drug safety.

    Frances Nolan, Vice President, Global Quality Assurance

    Nolan joined Medidata in December 2006 as Senior Director of
    Quality Assurance and was appointed Vice President of Global Quality
    Assurance in April 2007. In this new role, Nolan is responsible for
    ensuring Medidata products and services achieve and maintain
    compliance with industry standards and best practices. With more than
    30 years experience in the pharmaceutical and software industries,
    Nolan has extensive expertise in regulatory compliance, including
    electronic records/electronic signatures (including US FDA 21 CFR Part
    11), computer system validation and privacy and risk management. Nolan
    has held a number of positions in IT and quality assurance at leading
    companies including Taratec Development Corporation (now Patni), a
    regulatory compliance consulting company, where she drove compliance
    strategies and solutions. She also served as the worldwide head of
    Pfizer R&D's 21 CFR Part 11 Program and director of systems and
    services management for Pfizer's corporate clinical and regulatory
    systems group, and Oracle's U.S. director of customer satisfaction and
    quality. Nolan has been an active participant in the Industry
    Coalition on 21 CFR Part 11, a frequent presenter in global forums
    such as the DIA Annual Meeting and DIA Workshops and a contributor to
    the 2006 Red Apple 2 Conference on Computerized Systems for
    Non-Clinical Safety Assessment.

    Dr. Tony Hewer, Senior Director, Global Quality Assurance for EMEA

    As the Senior Director of Global Quality Assurance for EMEA, Hewer
    is responsible for refining and maintaining robust, up-to-date quality
    and regulatory standards for Medidata products and services. Hewer has
    more than 25 years experience in the pharmaceutical, IT, and
    management consultancy industries and most recently led a team of
    pharmaceutical IT QA professionals in Asia Pacific. He has held a
    number of senior IT management and leadership positions with Pfizer
    and also previously worked for Braxxon Technology Limited and Data
    Logic Limited in the wholesale banking industry in London,
    specializing in front-office systems as well as IT operational
    effectiveness.

    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.