Medidata Solutions Expands Clinical Trial Technology Offering with Acquisition of Fast Track Systems



    Medidata Solutions, a global provider of electronic data capture
    (EDC), management and reporting solutions, today announced the
    completion of its acquisition of Fast Track Systems, Inc., a provider
    of clinical trial planning software, proprietary contracting data and
    professional services. With this acquisition, Medidata extends its
    ability to serve customers throughout the clinical research process
    with technologies that improve efficiencies in protocol development
    and trial planning, contracting and negotiation.

    Fast Track has built a broad customer base, including 10 of the
    top 15 pharmaceutical companies, by delivering innovative products
    that automate activities across the clinical trial process to drive
    efficiency, accuracy and quality. For more than 16 years, sponsors
    have utilized Fast Track´s contract benchmark data and analysis tools
    to enhance relationships with investigator sites and contract research
    organizations (CROs). More recently, the company has developed the
    first commercial tool certified by the Clinical Data Interchange
    Standards Consortium (CDISC) to bring electronic management to the
    protocol development and study start-up process.

    "Fast Track´s unique focus on improving clinical trial design and
    execution truly complements our mission of providing sponsors with the
    most advanced tools for planning and managing clinical trials," said
    Tarek Sherif, CEO and co-founder of Medidata Solutions. "As a company,
    we will continue to pursue strategic opportunities that allow us to
    expand and enhance our offerings in anticipation of our customers´
    needs and further compete in a dynamic marketplace."

    After a year of continued revenue growth in 2007, Medidata has
    diversified its experience and expertise in clinical trial technology
    with the addition of Fast Track thought leaders and domain experts in
    trial planning and negotiation. Medidata will continue to operate Fast
    Track´s offices in Conshohocken, PA (Philadelphia area) and Ross, CA
    (San Francisco area), bringing Medidata offices to a total of eight
    worldwide. The former Fast Track executive management team, including
    CEO Ed Seguine, CTO Peter Abramowitsch and VP of Operations Lori
    Shields, have joined Medidata´s management team with a focus on trial
    protocol design, contracting and negotiation.

    Medidata and Fast Track first collaborated in February 2007 on the
    integration of Fast Track´s protocol development tool with Medidata
    Rave(R), Medidata´s electronic data capture, management and reporting
    solution.

    "This acquisition was a natural evolution of our initial
    partnership. It became clear early on that not only do our
    technologies integrate well, but that the two companies shared similar
    goals and approaches to making improvements in the way clinical
    research is conducted," said Seguine, Medidata´s new general manager
    of trial planning solutions. "Individually, each product in the
    Medidata portfolio improves the effectiveness of key trial planning
    and execution activities. As a combined company, we are able to help
    customers and partners realize greater value from their eClinical
    strategy by putting innovative technology and insightful data into
    researchers´ hands to facilitate their decision-making."

    Reaching More Members of the Clinical Research Team with New
    Capabilities

    Medidata has built its reputation among investigators and data
    managers for streamlining the clinical trial process through Rave´s
    easy-to-use data capture, management and reporting capabilities.
    Medidata´s expanded product portfolio now also offers protocol
    development, trial management and finance teams a consistent view of
    the critical operational data generated throughout the clinical trial
    execution process.

    -- Medidata Designer(TM) (formerly Fast Track TrialSpace Designer
    XCP(R)) - This cutting-edge protocol authoring and trial
    design tool helps guide clinical research teams through the
    protocol creation and study set-up processes. Beginning with
    structured protocol development, Medidata Designer can
    automatically configure other clinical trial systems - such as
    electronic data capture and management, data analysis and
    electronic data submissions - ensuring an automated
    environment for consistent, shared clinical and operational
    requirements. Medidata Designer:

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    -- Deploys a standardized protocol development methodology
    that assures quality consistency and continuity of trial
    protocols to more effectively execute the clinical plan;

    -- Retains organizational knowledge and builds company
    standards by populating a protocol warehouse with
    consistent study design parameters; and

    -- Facilitates compliance with CDISC SDTM data submission
    standards with the only CDISC-certified protocol authoring
    tool.
    *T

    -- Medidata Grants Manager(TM) (formerly Fast Track TrialSpace
    Grants Manager(R)) - This investigator site contract
    benchmarking tool helps trial managers optimize investigator
    grants by ensuring fair and consistent site payments and
    mitigating compliance risks. The only clinical cost database
    derived from negotiated agreements between sponsors and
    investigators, Medidata Grants Manager includes data from
    nearly one quarter of a million grants and contracts and more
    than 27,000 protocols in more than 1,400 indications in an
    Internet-based platform that:

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    -- Shortens the negotiation cycle and fosters rapid
    acceptance and active participation by investigators;

    -- Enables sponsors to make better informed and consistent
    decisions for controlling clinical investigator costs; and

    -- Facilitates strong teamwork with collaborative tools for
    review, editing and publishing budgets.
    *T

    -- Medidata CRO Contractor(TM) (formerly Fast Track TrialSpace
    CROCAS(R)) - This outsource planning and contracting solution
    puts data-driven analytic tools in the hands of research
    sponsors to optimally plan, budget and manage CRO
    relationships. Used by clinical, project management,
    contracting and finance professionals worldwide, Medidata CRO
    Contractor provides up-to-date data from more than 4,000
    sponsor contracts with more than 250 global CROs in an
    Internet-accessible, easy-to-use workspace that:

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    -- Reduces project delays with up-to-date and relevant
    information;

    -- Saves trial time and costs by ensuring accurate activity
    selection and costing;

    -- Speeds the preparation of requests for proposals and
    contracts; and

    -- Simplifies project start-up, project management and
    administrative control.
    *T

    "Our research at the Tufts Center indicates that protocol design
    is the lynchpin for streamlining downstream clinical research
    processes and improving drug development performance," said Ken Getz,
    senior research fellow at Tufts Center for the Study of Drug
    Development. "Research sponsors and CROs express a strong need for
    better protocol development and site management tools. Medidata´s
    acquisition of Fast Track Systems promises to help meet this large and
    growing need."

    About Medidata Solutions Worldwide

    Medidata Solutions (www.mdsol.com) is a leading provider of
    clinical trial solutions that enable the world´s most advanced life
    science organizations to maximize the value of their clinical research
    investments by putting powerful tools into researchers´ hands. A
    pioneer since 1999 in innovative technologies for planning and
    managing clinical studies - including protocol design; clinical data
    capture, management and reporting; and trial contracting and
    negotiation - Medidata Solutions and its global network of business
    partners address the unique needs of sponsors and sites of all sizes.
    With deep expertise in conducting studies across all phases and
    therapeutic areas, on six continents and in more than 80 countries,
    Medidata Solutions helps clinical researchers reduce trial cycle
    times, achieve early visibility to reliable clinical data, and
    maintain strict fiscal responsibility, while safely accelerating the
    process of bringing life-enhancing treatments to market.