Functional Service Provider (FSP)

Scrip – The CRO View: Sharing Opportunity Vs Risk In Drug Development

We hear a lot about risk-sharing in drug development these days, and it’s a healthy trend in an industry often defined by high costs and the pressure of project deadlines. Drug development thrives on cost and schedule adherence, and the inextricable link between the two leads increasingly to risk-reward arrangements between drug makers and their clinical research providers.

Having been involved in many of these, I like to avoid “risk-sharing” and other terms that can cast these agreements in a negative light. When we look at clinical development, I prefer to focus on opportunity-sharing — not so much avoiding failure as improving clinical trial productivity and efficiency.

After all, if you start a clinical development program assuming you’re going to fail, you’d better find something else to do.

First, A Definition

Risk- and opportunity-sharing is still a pretty new concept, and there are different types of these arrangements. In this article, I’m describing agreements between drug makers and clinical research organizations under which CROs are rewarded, or penalized, based on their performance versus contract terms and milestones.

Read more at Scrip.