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




    Three Senior Executives Bring More than 75 Years of Combined Clinical, IT
and Pharmacovigilance Experience

    NEW YORK, September 13 /CNW/ - 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.




For further information:

For further information: For Medidata Solutions Lois Paul & Partners
Susan Lombardo, 781-782-5767 Susan_Lombardo@lpp.com

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MEDIDATA SOLUTIONS WORLDWIDE

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