Successful Outsourcing: Tracking the Evolving Use of Full-Service and Niche-Service CROs - Applied Clinical Trials

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Successful Outsourcing: Tracking the Evolving Use of Full-Service and Niche-Service CROs


Applied Clinical Trials


Variance in the usage of regional CROs abroad is much higher than for multinational CROs. Interestingly, whereas expected 2005 usage of multinational CROs is consistent with 2004 levels, respondents expect a slight decline in the use of regional CROs abroad. This year, 59% of respondents expect regional CROs abroad to manage more than two projects, down from 66% in 2004. The variance among companies in the level of expected 2005 usage of regional CROs abroad has also widened.


Table 1. Planned use of CROs in geographical areas (percentage of respondents)
Planned use of CROs in various geographical areas is shown in Table 1. Most respondents expect CRO usage to increase or stay the same throughout most regions of the world during the next several years. Areas where the largest percentage of respondents expect their use of CROs to "increase" include Europe (47%); North America/U.S. (46%); and Central and Eastern Europe (36%). One out of 10 respondents expects decreasing use of CROs in several key regions: Latin America (9%); North America (9%); Europe (8%); and South Africa (8%).

Frequency of CRO service use It is encouraging to note that in the present survey, most sponsors believe that their outsourcing practices are more strategic in nature. Three out of four describe their use of CROs as deliberate and planned. Only 25% reported that they are frequently using CROs for "tactical" reasons (e.g., last minute decisions due to an unexpected shortfall in resources).

Respondents are evenly divided on their reported use of CROs for "functional" purposes. Half of the respondents (49%) report that their approach to outsourcing involves the transferring of a specific task across the majority of their projects.


Table 2. Use of CROs for various activities (percentage of respondents)
Table 2 shows the use of CROs for various activities. Activities most often outsourced include data collection/study monitoring (89% report "very often" or "occasionally"); preparing and collecting site documents (82%); patient recruitment assistance (82%); data management (77%); and investigative site selection (73%). Interestingly, compared to our 1994 survey results, sponsors appear to be scaling back somewhat in their reported use of CROs for traditional services, specifically monitoring and data management.

The present survey also suggests that sponsors are dramatically increasing their use of CROs to interface with and support investigative sites. Sponsors are also modestly increasing their use of CROs for development planning and protocol design. In 1994, for example, only 18% of companies used CROs for site selection; in the present survey 73% of the respondents report doing so. And in 1994, only 2% of sponsors reported that they rely on CROs to provide patient recruitment assistance. This compares with 82% of the respondents who report doing so in the present survey. Ten years ago, 6% of sponsor companies reported using CROs for development planning. In the present survey nearly half (49%) of the respondents report outsourcing their development planning activity.

CRO selection practices Asked if they are required to choose CROs from a preferred provider list or if they may make an argument to use someone not listed, slightly more than one-third of respondents (37%) report that they must choose from the preferred provider list. The practice of limiting choices to a preferred provider list appears to have softened slightly. In response to a similarly worded question in 1996 and 1998, 45% of respondents in each case reported that they were required to limit their CRO choices to those on the preferred provider list.


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