At first glance, it seemed no more complex than any other global, randomized Phase III study. The devil turned up in the details.
At first, screening failure rates were discouraging at best – between 60 and 70 percent. Premier Research responded quickly, by expanding the number of sites from 100 to 130, eliminating non-performing sites and encouraging the most successful sites with ongoing training and motivational programs.
Next was managing a major change of direction with no major loss of time. The study started with a single idea, but ended up including four different investigational medicinal products. It could have been a nightmare. Instead, it ended up as an opportunity to show Premier Research at its best, effectively dealing with the unexpected.