With more than two decades in the industry under his belt, Jeffrey Trotter had his own contract research organization (CRO) for more than a decade. He sold it—twice. And now he's helping to shepherd the late-phase strategy at PharmaNet Development Group, where his title is executive VP, Phase IV development. He supervises a 50-person group dedicated to such projects. All of the large, global CROs routinely work in post-approval research, Trotter notes. They can all be competent. But only a few firms, his included, truly specialize in Phase IV studies and appreciate the nuances. One respect in which his firm is different, he says, is in an immediate recognition that such projects are not simply carbon copies of Phase III studies. "This requires a different approach," Trotter says. "Most of the industry has been trained and shaped by traditional randomized clinical trials. Unless you can deploy those resources in a different…more...