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.
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.
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