Too Hot, Too Cold – Finding the Clinical Development Outsourcing Model That Is Just Right

By Sherry Hubbard-Bednasz

Let’s take a trip down memory lane – the good old days of original straightforward outsourcing. Have a gap in capacity? Outsource. Need access to research experience? Outsource. Pluck that card off the Rolodex and make the call to secure high quality at the best price. (Maybe we’re overstating the simplicity of the good old days a bit, but that’s what people do.) Nowadays, the reasons to outsource extend well beyond a single need for a single project. Gone are the easy buttons and linear decision-making. A significantly reduced in-house development infrastructure means a heavy reliance on external resources. And with that comes challenges in managing those external relationships and expectations.

Despite the intricacies of outsourcing, the trend continues to hold. Industry Standard Research learned in a recent survey that 61% of clinical development work is currently outsourced, on average. This metric is specific to the outsourcing community; those involved with in-house only activities are not included in this figure. This rate is similar to the outsourcing rates reported in previous versions of the survey: 66% in 2018 and 68% in 2015.

Let’s say you are sponsoring a novel clinical study that requires therapeutic expertise not available in-house, specific geographies, and remote/risk-based monitoring. In the past, this scenario would have been rare. Today, not so much. Let’s also say this study is one of several in your pipeline. Are companies engaging more than one outsourcing model to meet their needs? Yes, and with a little trial and error.