Post-Market Case Study

Medpace rescues study management for observational study of pacemaker and cardiac resynchronization therapy devices

After Medpace stepped in to get the study back on track, protocol deviations decreased 40% and data query issues also fell by more than 40% after the first year.

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 clinical trial management.

Challenges

At the time Medpace took over this project, some of the sites were unaware the research 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

Medpace seamlessly transferred site and data management responsibilities for this logistically complex research study which included 140 centers and 3,000 patients in the United States. Working closely with the sponsor, we 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. We 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. Medpace 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 questions.

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
  • Accelerated data entry and review timelines—nearly 100 percent of all data was reviewed in real time
  • Patient follow-up compliance improved by seven percent

Read More

Pre-market Case Study: Medpace helps accelerate submission and approval for non-implantable cardiac devices