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As outsourcing continues to be a key component of clinical trials, the ability to analyze the performance of CROs is of utmost importance to sponsor companies. KMR Group completed an analysis comparing the performance of outsourced versus internal trials, exploring how the CRO industry in general fares on a variety of key performance metrics for various outsourced services.
Figure 1. Trials with a wider scope-more than eight countries-tend to be outsourced more often than trials with fewer countries.
The Outsourcing Performance Study assessed recent Phase II and Phase III trials. About one-fifth of all trials are conducted internally, with no outsourcing. But geographic scope plays a role when deciding if there is a need to outsource. Trials with a wider scope—more than eight countries—tend to be outsourced more often than trials with fewer countries. There is no difference in the level of outsourcing for trials that are in fewer countries.
Given the reliance of outsourcing on trials with more complex geography, and the importance of these large scale studies to the success of sponsors, the question arises as to whether the performance is in line with industry standard trial performance benchmarks. The assessment answers these questions and offers the first framework for benchmarking outsourced studies. Nine biopharmaceutical companies participated in the study: AbbVie, AstraZeneca, Bayer HealthCare, Biogen Idec, Bristol-Myers Squibb, GlaxoSmithKline, Merck Research Laboratories, Roche, and UCB.
—KMR Group, https://kmrgroup.com.