How A Leading Sponsor's Metrics Were Exceeded For Global Vaccine Enrollment And DB Lock

A leading pharmaceutical company contracted with INC Research/inVentiv Health to conduct a large global vaccine study involving more than 900 elderly subjects, all of whom were 68 years of age or older, at more than 50 study sites. The study’s tight enrollment timelines and strict inclusion criteria increased the level of difficulty from the start: All sites had to be visited within two weeks of the first patient’s participation, a goal that was made even more difficult by many subjects’ uncertainty regarding their prior vaccination history.

INC Research/inVentiv Health quickly organized and assembled a highly capable cross-functional operational team that:

• Identified study sites with prior INC Research/inVentiv Health experience in vaccine studies to minimize enrollment time.
• Utilized operations personnel already familiar with the selected sites and the client’s electronic data capture process to maximize study conduct efficiency.
• Developed effective internal and client-focused communications plans to identify potential issues as early as possible and provide adequate time for preemptive corrective action.
• Coordinate and internal cross-functional effort to expedite completion of study files, allowing database lock to occur three months ahead of schedule.

INC Research/inVentiv Health also worked within the client’s program of studies to identify and incorporate efficiencies that would improve operations, resulting in a significant acceleration of multiple processes.