Meeting an Aggressive Timeline in Support of a Companion Diagnostic in Women's Health

A pharmaceutical partner was developing a new treatment for women undergoing in vitro fertilization. Initially, the company had not included a companion diagnostic (CDx) in its clinical strategy, but as the clinical program progressed, it became clear that such a test would be necessary to seek regulatory approval. As the start of the Phase III trial was rapidly approaching, the company needed to fast-track the CDx program and looked to Covance to help meet the accelerated timeline for the pivotal clinical trial needed to support the co-development of the pharmaceutical agent and its accompanying diagnostic.