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Medidata Solutions Partners with Fast Track Systems to Accelerate Enterprise-Wide Deployments of Electronic Clinical Trials



    Medidata Solutions, a global provider of electronic clinical data
    capture, management and reporting solutions, today announced its
    partnership with Fast Track Systems, Inc., a provider of clinical
    trial design software and professional services. The companies have
    entered into a multi-year agreement to integrate Fast Track's
    TrialSpace Designer(R) (TSD) study design software with Medidata
    Rave(R), the industry leading EDC platform.

    Traditionally, study design and EDC study build have been thought
    of as separate activities. Sponsors have prepared protocols and
    statistical plans using simple desktop applications that lack the
    intelligence to identify potential inconsistencies throughout these
    lengthy documents. In addition, EDC roll outs have required
    significant implementation and validation activities for each study.
    The combination of TrialSpace Designer and Medidata Rave integrates
    these two previously separate activities and creates a seamless flow
    of information from initial study design through electronic case
    report form (eCRF) build and beyond.

    Customers leveraging the combined solution can optimize their
    clinical development practices through Fast Track's easy-to-use design
    tool to seamlessly create both study documents and standards-based
    study data models. Expanding on Rave's existing capabilities around
    rapid study build and deployment, this partnership allows automatic
    implementations of CRFs and workflow for studies based on electronic
    study design standards.

    "As the industry struggles to contain rising development costs,
    the combined solution of TrialSpace Designer and Rave will reduce
    costly inefficiencies and expand execution capacity by automating many
    complicated study start-up processes," said Ed Seguine, CEO of Fast
    Track Systems, Inc. "The capability of TSD to initially capture and
    model complex trial design information perfectly complements Rave's
    ability to efficiently configure and manage this data throughout the
    execution lifecycle. The vision of a truly integrated study design and
    execution suite is indeed a reality."

    With this partnership, sponsors will be able to use TSD to define
    a clinical trial protocol, statistical plan and operational details,
    then export the information according to the CDISC operational data
    model standard. From there, the exported data can be used to set up an
    EDC-based trial using Medidata Rave's Architect Loader, an XML-based
    study build tool.

    "Fast Track's break-through protocol authoring and study design
    technology integrated with Rave will allow us to deliver our customers
    an optimal solution for executing clinical trial operations from study
    design through data capture and clinical data management," said Glen
    de Vries, CTO of Medidata Solutions. "We've already achieved a 50
    percent reduction in study configuration requirements, and with our
    continued work together combined with rapid reusability offered by
    Rave's Global Library, we expect to reduce the workload for study
    deployment even further."

    About Fast Track Systems, Inc.

    Fast Track's products reduce cost, increase compliance, and
    improve productivity by solving problems associated with the
    operational aspects of clinical trial design and execution. TrialSpace
    Designer ensures greater consistency and transparency in trial design
    by capturing study design information as reusable data that can be
    utilized by other clinical systems and leveraged for related purposes.
    Grants Manager and CROCAS draw from over 25,000 finalized protocols,
    240,000 negotiated grants, and 4,000 CRO contracts to ensure that
    subscribers understand the true cost and compliance consequences when
    negotiating clinical agreements. Visit www.fast-track.com for more
    information about our products and services.

    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.