Increased focus on post-market safety and value has resulted in CROs handling more Phase IV work, according to a PharmaNet EVP, and this trend may continue as regulators seek real world evidence.
Jeff Trotter, executive vice president of Phase IV development at PharmaNet, told Outsourcing-Pharma that “the real world is real important”. In recent years post-market safety has become increasingly important, boosting Phase IV business for contract research organisations (CRO).
This is now being accompanied by increased focus on value. Trotter said this spans other indications, cost-effectiveness and comparative effectives. More and more regulators will request post-approval data to prove a product has lived up to promise, said Trotter.
In April PharmaNet made three executive appointments to its Phase IV team.