Reining In The CRO Oversight Quagmire

By Craig Morgan, Oracle Health Sciences

As the complexity of clinical trials continues to increase the importance of contract research organizations (CROs) to the pharmaceutical industry has increased significantly. This outsourcing trend is being driven in response to the ever-increasing size, regulatory demands, duration, and cost of clinical trials. Outsourcing allows pharmaceutical companies to utilize on-demand services, improving operational efficiencies by accessing therapeutic expertise and geographic reach. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.

The relationship between sponsors and CROs is strengthening as outsourcing becomes a clinical trial mainstay. Yet, outsourcing of clinical trials introduces additional complexities around quality, oversight, collaboration, and governance. With outsourcing, processes and systems are often duplicated or disparate. Because sponsors often have multiple studies running concurrently with multiple CROs, oversight is complicated. Sponsors can’t benchmark CRO performance across their studies and therefore are unable to build-up institutional knowledge and competitive business intelligence, nor can they monitor ongoing performance to identify potential bottlenecks, having to rely instead on scheduled, and frequently outdated, status reports. Communication and transparency are required to move the clinical trial forward efficiently, but how can you do this when you’re working with multiple CROs all using inconsistent reporting conventions?

Simply handing off multi-million-dollar studies to CROs without carefully crafted plans for communications and reporting operational data as the study unfolds is hardly a wise move, yet what kind of oversight is needed?