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Offices

Medpace Medical Device
3787 95th Avenue
Suite 100
Blaine, MN 55014 USA
Tel: +1.612.234.8500
Fax: +1.612.234.8501

Medpace Medical Device B.V.
Maastrichterlaan 127-129
NL – 6291 EN Vaals
Tel: +31.43.306.3320
Fax: +31.43.306.3338

MMD E-mail: info.mmd@medpace.com

GENERAL CAPABILITIES


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    Global, Full-Service Medical Device Study Planning and Execution

    Medpace Medical Device (MMD), a full-service division of Medpace, has the broad experience, global resources and local knowledge required to help our medical device clients bring products to market safely, effectively and efficiently. Exclusively dedicated to designing and conducting medical device trials, MMD is managed by a team with extensive device industry experience who understands the unique nature of device trials and offers our clients the following advantages:

    • Improve efficiencies and time-to-market with effective regulatory guidance through early device development, clinical studies, regulatory approval or post-market studies
    • Customized and streamlined approaches to study design and execution
    • Studies kept on track with quick resolution of issues and risks
    • Expedited site activation and patient recruitment through a unique study management model
    • Accurate, timely metrics and actionable data

    The Medpace Difference for Medical Device Studies

    Medpace Medical Device leaders take clients’ goals, operational preferences and communication needs into consideration in order to customize study designs and execution strategy. This ensures efficiencies and reduces risks throughout the studies. Our medical device clients also benefit from:
    • Medpace physicians who are fully engaged throughout the study to ensure your trials start and stay on the right path
    • Established relationships with clinical research sites, key opinion leaders and therapeutic networks experienced in medical device trials allows Medpace to select the ideal geographies and sites to ensure the study is completed in a timely way
    • Device headquarters in Europe that is ISO-9001 certified and can serve as your European authorized representative
    • Project managers with significant experience in medical device clinical trials and long-term tenure with Medpace help ensure consistent, stable, reliable execution across all studies
    • Unique study management model, with dedicated in-house site managers supporting each site through study start up, site activation, enrollment and data review to ensure each milestone is met as efficiently, rapidly and effectively as possible
    • Robust data management tools and real-time data review model to ensure efficient and timely execution of all data-related matters, provide accurate and timely metrics to sites and sponsors, and to help limit any data-related risks
    • ClinTrak®, Medpace’s multifunctional, proprietary study management system to track, integrate and communicate trial information in a timely, secure and cost-effective way
    • Established procedures and expertise managing clinical events committees (CECs) and data safety monitoring boards (DSMBs)
    • Integrated, in-house ancillary services such as Imaging Core Lab, centralized ECG management services and central laboratories