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Medical Device Post Market Case Study
Medpace Medical Device - Case Study


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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

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  • Post-market:
    Getting Trial Back on Track

    A large medical device company no longer had enough internal resources to continue to conduct this comprehensive, five year, US-based post-market observational study of pacemaker and cardiac resynchronization therapy devices. In the second year of the study, this sponsor company contracted with Medpace Medical Device to take over study management.

    Challenges

    At the time MMD took over this project, some of the sites were unaware the study was still ongoing and there were a large number of protocol deviations, a high number of open data queries, poor patient compliance and a high patient attrition rate. The sponsor company was experiencing turnover on their study team so the study lost momentum and lacked continuity.

    Solution

    MMD seamlessly transferred site and data management responsibilities for this logistically complex study which included 140 centers and 3,000 patients in the United States. Working closely with the sponsor, MMD developed a site-specific transition plan tailored to the needs of each site and dedicated site resources to work closely with the sites to help them understand and adhere to the protocol. MMD also held coordinator meetings to facilitate open discussions regarding common issues faced at the sites, which proved to be effective in collectively resolving issues and keeping the sites engaged. MMD focused on data integrity and reviewed very close to 100 percent of data in real time to provide timely feedback to the sites and to proactively address any questions the sites may have.

    Result

    • Decreased protocol deviations by 40 percent
    • Reduced data query issues by more than 40 percent after the first year
    • Reduced 1,200 outstanding data queries by 75 percent within the first three months
    • Speeded data entry and review timelines—nearly 100 percent of all data was reviewed in real time
    • Patient follow-up compliance improved by seven percent