Sponsor Oversight of CROs

The perennial sponsor complaint: "Outsourcing costs too much." The perennial CRO response: "If you didn't assign so much internal resource to manage us, it would be cheaper."

Well, it's true and both groups acknowledge it. Over 90% of sponsor and CRO respondents indicate that resources are assigned to oversee outsourced studies. While CROs and sponsors agree that oversight may be excessive, they do not agree on the consequences. In ISR's Staff Quality and Models report, 78% of CROs believe that oversight increases the amount of time necessary to complete a clinical trial compared to only 25% of sponsors. Sponsors hold what may be considered contradictory beliefs regarding their oversight of CROs. They believe their own oversight to be excessive; however many believe there are benefits too. Nearly half of the sponsor respondents indicated oversight reduces time; 53% believe it either reduces costs or has no impact on costs; and 77% believe it increases data quality.

From ISR's perspective, the size, global scope, and complexity of today's clinical trials are justification enough for a degree of oversight. Pharma's business challenge is identifying when enough is enough; the point when investing in more oversight no longer returns a better clinical trial. Service providers' business challenge is to better understand why sponsors insist on oversight, and then develop systems, training, and people to arrive at the right balance.

This is an evolving issue and having a better understanding of development outsourcing models as well as sponsor and service provider oversight rationale are important first steps to increasing trial efficiency and lowering industry clinical development spending. Achieving the right oversight balance can have profound effects on both individual development programs and companies.

—Industry Standard Research, www.ISRreports.com