Study Start-Up Takes Longer For CROs: Results from KMR Group Outsourcing Performance Study

KMR Group

, a leader in analyzing R&D performance data for the biopharmaceutical industry, has completed a detailed assessment of outsourced vs. internal trials, reviewing how the CRO industry in general compares on a variety of key performance metrics.

As biopharmaceutical companies aim to control trial costs and reduce timelines while efficiently managing resources, deciding how and when to outsource has become a crucial challenge. But there has been little unbiased, concrete data available to place these decisions in a performance context, where trial outcomes can be better understood across a range of studies that were managed internally vs. externally. The Outsourcing Performance Study offers such data through its analysis of recent Phase II and III trials. Nine major companies participated.*

The Study assessed 14 core metrics, such as Site Initiation Rate, Site Non-enroller Rate, Screen Failure Rate, Protocol Deviation Rate, Meeting Planned End of Randomization Target, Data Capture Cycle Time, Query Rate. On some of the metrics there is no substantial gap in performance for outsourced vs. internal studies but in six there are notable differences. The Study examines these and the factors that influence them.

One metric with a difference is the Study Start-up Cycle Time (protocol approval to start of randomization). Across the range of Industry performance, Study Start-up Cycle Time is 15% longer when the Site Selection or Site Start-up service is outsourced compared to when it is done internally. Setting realistic expectations for this variance, and examining the factors that drive it, can help both sponsors and CROs.

"The Outsourcing Performance Study offers a data-driven comparison of internal vs. outsourced trials based on a sizable set of actual trial data. It offers an important basis for helping sponsors and CROs first understand and then improve their performance. The focus was on the Industry at large but it is noteworthy that certain sponsors and CROs consistently out-perform their peers for specific processes. The results can therefore shed light on operations and help improve the working relationships between particular sponsors and CROs,” according to Scott Martin of KMR Group.

* AbbVie, AstraZeneca, Bayer HealthCare, Biogen Idec, Bristol-Myers Squibb, GlaxoSmithKline, Merck Research Laboratories, Roche, UCB.

For more information on the Outsourcing Performance Study contact:
Scott Martin, Principal Tel: +1 (312) 795-0400 Email:

[email protected]