The capitalized cost to develop an approved new drug has doubled in a decade. Why?

First, growing complexity in clinical trial protocols makes it more difficult to manage studies efficiently. One measure of complexity – procedures per protocol – has increased by over 50% since the early 2000s. And more complex protocols take 73% longer to complete.

At the same time, the need for speed and quality in clinical trials has never been greater. Compromised data quality has prominently made recent front page news in the form of Theranos and other Silicon Valley sponsors facing significant challenges from the Food & Drug Administration (FDA).