Data Management & Biostatistics

Premier Insight 240: Getting Every Detail Right – With No Time to Think About How

Our customer was racing to beat a competitor to registration. One critical part of the timeline: Last patient out to database lock in two weeks. In sister studies that involved 800 patients at 90 sites. And several primary investigators who were heading off on vacation just when we needed their sign-offs on the data. We also had to coordinate the efforts of a central laboratory, PK data people, a data management company, investigators and site staff. That left us with ultimate responsibility but no direct control over the other participants.