Harold E. Glass

Overall, sponsor companies and CROs have a fairly consistent view of the criteria used to select CROs, although there are some notable differences. The pharmaceutical industry makes widespread use of CROs and, most likely, this trend will increase in the coming years. But little empirical research exists on why and how pharmaceutical companies select CROs.  

The University of the Sciences in Philadelphia (USP) and TTC, a drug development data company, are conducting a multiyear research program on the factors associated with improved speed and cost effectiveness in clinical studies. Since outsourcing to CROs represents an integral part in developing drugs, USP and TTC will also analyze how CROs are selected and used in clinical trials. Part of this CRO analysis involved a Web-based survey of sponsor pharmaceutical companies and CROs to understand the following:  

Specific outsourcing processes and techniques, such as project budgeting, CRO selection, managing studies, bid grids, and managing cost overruns

Perceptions of how CROs and sponsor companies interact in the areas of business development, CRO selection, and project management

Training needs for professionals to improve CRO selection and CRO project oversight.

Previous studies have reported that industry professionals involved in outsourced clinical studies expect the overall level of outsourcing to continue to grow. In addition, quality and timelines of a CRO's work dominate as the basic selection criteria.

  This article accepts that previous work quality is a central criterion for selection and focuses on other issues that might be involved in the CRO selection. Set within the anticipated continued growth of CRO usage, the article examines these additional key criteria that individuals working in drug development use to select CROs, highlighting the differences between the selection criteria that sponsor companies emphasize and how CROs think sponsor companies decide. 

Using factor analysis, we also determined that the individual elements used to select CROs can be summarized within a set of five broader dimensions: Processes for Issue Identification and Resolution; the Specifics of Project Execution; Team Chemistry; CRO Experience; and CRO Capabilities. 

Pharmaceutical company participants indicate that approximately two thirds (64%) of all post Phase I studies involve the use of CROs for one or more parts of the study. However, when measured by pharmaceutical company size, there are very large differences in current outsourcing practices. For example, within the largest 20 pharmaceutical companies, half (52%) of all post Phase I studies use CROs, a number that jumps to 88% for smaller companies. These smaller pharmaceutical companies often do not have the permanent in-house staff to conduct all aspects of a clinical trial, especially where the trial involves many sites and multiple countries. The smaller companies may, for any number of reasons, also lack the employee headcount or expertise to carry out clinical trials. 

While many industry professionals expect the use of outsourcing to increase [see Table 1], only one quarter of people from pharmaceutical companies think that their company is better than competing companies in selecting CROs, with no significant differences based on the size of the companies involved. That is, large companies are no more likely to think they are especially good at CRO selection than are small companies. Similarly, there are no appreciable differences based on a participant's geographic location, whether it be North America, Europe or other locations worldwide. There is a slight but statistically insignificant difference in the age of individuals who think their company is better than others in selecting CROs—they are a year older, but have the same number of years of industry experience.  

There is a general agreement between the reasons pharmaceutical companies cite for selecting an outsourcing organization and how CROs think pharmaceutical companies select them. There are also some striking differences in the individual decision criteria. Survey participants evaluated 17 individual considerations often used in selecting a CRO and rated each item on a scale ranging from very important to not important at all [the 17 criteria arose from our literature review and preliminary interviews with industry professionals]. Five of these 17 items were deemed to be especially crucial in the selection of CROs—that is, specified by at least half of all the study participants. 

The most important overall quality in selection is a sense of positive sponsor–CRO project team relationship. Both sponsor company and CRO respondents think that the sponsor wants to know above all else that they could work with the CRO. More than any other single selection criterion, sponsor companies stressed the importance of a good relationship between the two company teams. These teams must work closely with each other for an extended period of time, often on projects involving multiple countries and large sums of money. The sponsor company needs to know that both its team and the CRO's team share the same values, work ethics, and general approaches. CROs also clearly understand the need sponsors have for teams that work well together.  

The CRO's project management team contributes significantly to the overall positive sponsor–CRO project team relationship. Yet sponsors were far more likely than CROs to stress the importance of the project management team as a CRO selection criterion. While more than two thirds (68%) of the pharmaceutical company participants stressed this criterion in their selection process, only half (51%) of the CRO respondents thought sponsor companies valued this as very important. 

Sponsor companies and CROs placed great weight on a CRO's relevant experience, both in the same indication as the study and in the CRO's overall experience in the appropriate therapeutic area. Sponsor companies and CROs differed somewhat on the importance of a project member's background. While only 45% of the pharmaceutical company participants considered this very important, 62% of the CRO respondents considered it very important to sponsor company decision makers. Sponsor companies seem more interested in the overall cohesiveness of the CRO team members than their vitae. A vitae may be a constructive starting point, but positive sponsor–CRO project team relationship is vital to the project's success. As one pharmaceutical company project manager put it: "CVs can only take you so far. You want to know that the CRO's team fits with the way you want things done and the way you want to work." 

Another essential criterion (i.e., raised by more than a third of the study's R&D professionals), was the project execution plan. On no other single criterion, though, was there a greater difference between sponsor company and CRO responses. Fifty-nine percent of pharmaceutical company professionals considered the execution plan as fundamental in hiring a CRO; only 28% of respondents from CROs placed the same importance on the execution plan. 

In their responses to this criterion, the pharmaceutical company decision makers appear to be emphasizing a level of project specificity that many of the CROs may not appreciate. Far more than the CRO project team's background, pharmaceutical companies want to see a convincing project execution plan, including such concrete items as resources, countries, and site selection. According to one pharmaceutical company outsourcing professional: "Every CRO claims to be customer oriented, responsive, and so forth. Exactly how a CRO proposes to carry out a project...now that can be convincing—or not." 

Sponsor companies are also more likely to value the internal processes CROs use to make appropriate senior CRO managers aware of project problems. Forty-seven percent of the pharmaceutical company participants considered this capability to be essential in selecting a CRO. In contrast, only a third (34%) of the CRO respondents thought it was essential for sponsor companies. 

A smaller number of respondents, from both sponsor companies and CROs, considered the CRO's role as a preferred provider and the CRO's geographic scope to be very important. CRO staff turnover was somewhat more critical to the sponsor companies than many CROs thought was the case. 

Of the remaining criteria, one in particular merits its own discussion: the role of the lowest price bidder. Sponsor companies and CROs differ in how they view the role of the lowest price. According to an experienced business development manager from a major CRO, "Pharmaceutical companies rarely say price is important. But we know that it really is." But in this study, fewer than one in 10 (7%) of the sponsor company respondents considered the lowest price as decisive in selecting a CRO. In contrast, more than a third of the CROs (38%) felt price was a fundamental selection measure for sponsor companies. 

There were major differences in the importance the survey participants placed on the 17 individual items. People rarely make decisions using one consideration at a time. Rather, they relate one consideration to another and decide what's best. Companies follow the same process in selecting CROs. In fact, as mentioned earlier, sponsor companies use five general dimensions in evaluating and selecting a CRO:   

Processes for Issue Identification and Resolution

The study used factor analysis to distill these five dimensions from the 17 individual survey items. 

Factor analysis only provides a mathematical solution to how the various items relate to each other and how they relate to any underlying dimensions. Factor analysis does not label the individual factors. Items heavily associated with a factor are said to "load on" that factor. Items that load more heavily than others have a bigger explanatory role in understanding the communality of the items associated with that factor. Only a review of the items associated with a given factor can provide a rationale for what the individual items may have in common.  

The individual factors appear in the order of the variance they explain, which is often a function of the number of individual items "loading on" that factor. That order does not necessarily mean that a given factor's explanatory importance is more or less than the factors before or after it. [Table 2, available on the 

 Web site, summarizes which of the individual selection criteria load on each factor; a more complete matrix can also be found on the Web site.] 

In this survey, five items load heavily on the first factor, Processes for Issue Identification and Resolution. The individual items all concern the same general issue area: processes used to identify and resolve project and financial issues. Three items are associated with the second factor, the Specifics of Project Execution. Critically, price is inversely related to the other criterion in this factor. The more participants stress the other two items of the factor—quality of the project team and the project execution plan—the less likely they are to emphasize price. Conversely, those who stress price put less weight on the quality of the other items in the factor. The third factor covers the Project Team's Chemistry, including the individuals, their backgrounds, staff turnover rates, and the sponsor company's sense that they can work with the CRO's personnel. Two items, both related to relevant CRO experience, load on the fourth factor: CRO Experience. The fifth factor addresses items associated with a CRO's Capabilities, including the CRO's relationship to the sponsor company.

The factor analysis provides a score for each individual for each factor. The higher the score for an individual participant on a factor, the more prominent that dimension is to the individual. The relative importance of these five decision-making dimensions differs within key groups involved in selecting and using CROs. For example, sponsor companies and CROs view the importance of one dimension, the Specifics of Project Execution, quite differently.

As we have seen, sponsor companies value the quality of the execution plan far more in selecting an outsourcing partner than many people in CROs realize. CRO personnel tend to think that price plays a larger role in the selection process than sponsor companies do. There is also one important difference that relates to an organization's size. Participants from the 20 largest organizations, whether they are sponsor companies or CROs, differ from individuals in smaller organizations on one decision-making dimension: CRO Capabilities.

Larger pharmaceutical companies and CROs give more weight to a CRO's size, geographic reach, and relationship with the sponsor companies. Large organizations, both sponsor companies and CROs, may be more comfortable working with one another as large organizations, especially for bigger studies requiring extensive geographical coverage.

The greatest differences across the dimensions are associated with a respondent's geographic location. The components of the CRO selection criteria are important to both Europeans and Americans. However, Europeans and Americans do differ on three of the dimensions. 

For example, Europeans are far less interested than others in the details and mechanics of identifying and resolving issues and, ultimately, in a CRO's willingness to accept accountability. Americans are more likely to consider Execution Specifics and CRO Capabilities important. They want to see the details of the project plan and project management team devoted to the study. They are more interested in a preferred provider relationship with a larger CRO having geographic reach. 

While Americans stress the mechanics of the CRO/sponsor company relationship, Europeans tend to emphasize more intangibles. These differences by a respondent's geographic location remain significant even when we use ANOVA (analysis of variance) to control for the possible influence of other variables, such as company size and whether a person works for a CRO or sponsor company. 

Most of the pharmaceutical companies surveyed believe that they are on the same skill level as their competitors in selecting CROs, although a few believe that they are more adept at the process. Interestingly, there is no difference in the selection criteria between those companies who believe they are better at CRO selection and those who do not. No matter how well a survey participant's company believes they handle CRO selection, there is no difference when it comes to the five dimensions of selecting a CRO. 

In later research we will examine in more detail the impact of geography in how people approach CRO selection. In addition, we will also present the profiles of companies who do consider themselves better at selecting and managing CROs. 

, PhD, is a professor of health policy at the University of the Sciences in Philadelphia and the president of TTC, llc, 4548 Market St., Suite M-20, Philadelphia, PA, 19139, email: 

, MBA, is an associate director at TTC, llc.

*To whom all correspondence should be addressed.

1. T. Hintz, "Premiere of Exclusive Survey Results: Sourcing Models that Create Value in CRO Partnerships," 16th Annual Partnerships with CROs and Other Outsourcing Providers Conference, IIR, April 14–16, 2007. 

Articles

A recent survey uncovers key criteria that influence a sponsor's decision when selecting a CRO.

Key Factors in CRO Selection

The use of CROs, an expanding multibillion dollar business, is expected to continue its growth in the coming years.

  And since overall R&D costs and productivity represent one of the most pressing issues industry leaders face today,

  outsourcing will almost certainly continue to play a major role in drug development. 

(PHOTOGRAPHY: STEPHEN E. MUNZ   ILLUSTRATION: PAUL A. BELCI)

The University of the Sciences in Philadelphia (USP) and TTC, llc are conducting a multiyear research program on the factors associated with improving the speed and cost effectiveness of clinical studies, including the role of outsourcing. 

Our research study includes a Web-based survey of sponsor pharmaceutical companies and CROs in a range of areas, from how CROs are used to the process of selecting and managing a CRO. Other papers in this project have addressed a number of these CRO-related topics.

In this study, participants identified two related, yet distinct, outsourcing management areas: selecting a CRO and managing a CRO. 

We found that a company that considers itself as performing well in managing a CRO tends to believe that it is good in the previous step of selecting a CRO. Similarly, companies skilled at CRO selection also consider themselves to be especially competent in the management processes that lead up to selecting a CRO, such as using a common bid grid. However, the reverse does not hold true. Respondents in companies that consider themselves effective in selecting CROs do not necessarily assert that they are adept at the subsequent step of managing a CRO. 

Managing outsourcing involves many areas and processes. This study examined four key outsourcing-related activities: annual budgeting, the use of bid-grids, CRO selection, and the management of outsourced projects. 

The annual budget sets the operational parameters for almost every organization. Tracking and understanding operational variances from budgeted numbers is a demanding task, both for those who collect the numbers and for those who make decisions based upon those numbers. 

Yet few sponsor company participants in this study thought their ability to budget annually for outsourced studies was more effective than their counterparts' in other companies. But even fewer considered their company less effective than competitors in the budgeting process (see Figure 1). 

As one senior outsourcing manager put it: "Budgeting is something we need to get right, but often do not. Many times, though, it is really because the scope of the project changed, and no company will ever be able to anticipate all the changes. We could still do a better job of budgeting...particularly because no one likes having to go back for more money." 

There is a large variation in the way study participants evaluated their company's ability to select CROs, a greater variation than we found in their responses to the use of budget and bid grids. Although most participants felt that their company was similar to others in its ability to select a CRO, a third of those surveyed thought their company was better than other companies in selecting a CRO. At the other end of the spectrum, fewer than one in 10 considered their company to be ineffective in selecting a CRO. 

Apparently, the ability to effectively select a CRO is not concentrated in any particular pharma company, whether large or small, or limited to a particular geographic area. 

In addition, companies who consider CRO selection a competitive strength do not outsource an appreciably greater percentage of clinical development work. Moreover, these companies use CROs in much the same way: as preferred providers, full service providers, functional providers, single area outsourcing, or insourcing (see Table 1). 

Both sponsor company and CRO participants evaluated the importance of the set criteria many pharma companies use in selecting a CRO. Generally, while all participants strongly agreed on the selection criteria, some thought particular criteria were more important, while a smaller number of respondents cited very specific criteria as being most important. 

CRO selection criteria deemed most important were: the team's general sense they can work with the CRO, and a project management team devoted to the study. The criteria judged least important included: CRO invoicing/billing processes, and being one of the largest 20 CROs. 

Overall, companies that consider themselves better at selecting CROs generally use the same selection criteria as companies who do not consider themselves as adept at it. Still, depending on the type of company surveyed, there were important differences for a few of the selection criteria. 

For example, larger sponsor companies emphasize a CRO's size and geographic capabilities more than smaller companies. American pharmaceuticals value the mechanics of issue identification and resolution more than their European counterparts. Examples of these mechanics include a CRO's willingness to accept penalty clauses for poor performance, and an established process within a CRO to bring project problems to the attention of senior CRO managers. 

American participants were also likely to stress the detailed operational components of the CRO's approach. A case in point is the project execution plan the CRO presents in the bidding process, including items such as resources, country, and site selection. 

Respondents located in Europe, or from smaller companies, felt they were somewhat or clearly better than other companies in managing CROs. More Europeans than Americans (52% vs 31%) believed their company was better than others in managing CROs. Smaller pharmaceutical company respondents were more likely than survey participants from the largest 20 companies (54% vs 40%) to think they were better than others in managing CROs (see Figure 2). 

The European sense of being better at managing CROs may come from how they view CROs in total, and how their views differ from the American perception of CROs. 

For example, European participants are less severe in the evaluation of CROs on a series of operating dimensions (see sidebar). They were more likely to give CROs the benefit of the doubt in a range of areas such as communication problems, motives, and commitment to quality work. 

Operating Dimensions used to Evaluate CROs 

Americans and participants from larger companies were more likely to question CROs than were Europeans and respondents from smaller sponsor companies. Americans, especially in larger companies, often thought that the CRO would be more focused on getting the next project than performing well on the current project. 

Americans were also less likely to concede that the sponsor may often be the source of the communication problems on an outsourced project. And Americans were more prone to think it is more expensive to do work with a CRO than to perform the same work internally. 

Pharma company participants in this study report that, on average, their companies spend 27% of total CRO expenses on overseeing CRO projects. And there is no statistically significant difference between the better and poorer managers of outsourced work in the amount they spend on oversight. 

Nor are the companies who consider themselves better at managing CROs more likely to use fixed price contracts; they used fixed priced arrangements for 39% of their CRO contracts compared to 38% for the other companies. 

Similarly, there are no significant differences in the average amount of final budget variance due to scope changes (14% and 16%), or variance due to factors outside of changes in scope (12% and 11%). 

Companies that consider themselves better at selecting CROs also view themselves as better at major activities immediately prior to the final selection of a CRO. 

These companies are better at annual outsourced budgeting and use a better bid grid. They also use CROs with some slight variations: They make greater use of insourcing and draw less on full service providers. 

Study participants from clinical operations and contract management/finance rated their companies slightly higher on selecting CROs than did individuals from other corporate areas. This is likely due to the fact that they are more directly involved in areas related to selecting a CRO, such as using bid grids and annual outsourcing budgeting. However, in the final model a respondent's functional area was not significant. 

Respondents who consider their companies to be better at managing CROs are more likely to come from smaller pharmaceutical companies, be located in Europe, and perceive themselves as better at selecting CROs. Additionally, they see their use of preferred providers declining over time. 

Both groups—those who do and do not think they are better at managing CROs—share similar attitudes about how CROs operate and how the sponsor company should interact with the CRO. These shared attitudes include:  

The importance of a working partnership between a CRO and the sponsor company

The extent to which a sponsor company must closely monitor the details of a CRO's performance

The belief that CROs look for every way to increase billing on a given project, even at the expense of quality. 

However, the self-identified "better managers" of CROs tend to take a broader view of communication problems in outsourced projects. These better performers are more willing to acknowledge that communication problems are likely to originate with the sponsor company. Companies that are better at managing CROs also think they are better at selecting a CRO. But they do not necessarily think they are better at budgeting or using better-quality bid grids. 

Project managers and individuals in clinical operations are more positive in their views of how their companies manage CROs. But, once again, functional area did not appear as a statistically significant variable. 

Clearly, individuals may think their company is particularly good at the steps involved in outsourcing, but generally respondents—regardless of their functional area—identified two key decision loci: CRO selection and CRO management. 

Every company must critically evaluate itself on the individual dimensions it considers critical in managing outsourcing and develop steps to bring its actual practice into line with expectations. This process can include tools and information to better manage budgeting, the RFP process, and bid grids, and to better select and manage CROs. 

Study reveals how sponsors rate their own outsourcing abilities compared to other companies.

CRO Selection & Management

Overall, sponsor companies and CROs have a fairly consistent view of the criteria used to select CROs, although there are some notable differences. The pharmaceutical industry makes widespread use of CROs and, most likely, this trend will increase in the coming years. But little empirical research exists on why and how pharmaceutical companies select CROs. 

 This article accepts that previous work quality is a central criterion for selection and focuses on other issues that might be involved in the CRO selection. Set within the anticipated continued growth of CRO usage, the article examines these additional key criteria that individuals working in drug development use to select CROs, highlighting the differences between the selection criteria that sponsor companies emphasize and how CROs think sponsor companies decide. 

While many industry professionals expect the use of outsourcing to increase [see Table 1], only one quarter of people from pharmaceutical companies think that their company is better than competing companies in selecting CROs, with no significant differences based on the size of the companies involved. That is, large companies are no more likely to think they are especially good at CRO selection than are small companies. Similarly, there are no appreciable differences based on a participant's geographic location, whether it be North America, Europe or other locations worldwide. There is a slight but statistically insignificant difference in the age of individuals who think their company is better than others in selecting CROs—they are a year older, but have the same number of years of industry experience. 

Team chemistry. The most important overall quality in selection is a sense of positive sponsor–CRO project team relationship. Both sponsor company and CRO respondents think that the sponsor wants to know above all else that they could work with the CRO. More than any other single selection criterion, sponsor companies stressed the importance of a good relationship between the two company teams. These teams must work closely with each other for an extended period of time, often on projects involving multiple countries and large sums of money. The sponsor company needs to know that both its team and the CRO's team share the same values, work ethics, and general approaches. CROs also clearly understand the need sponsors have for teams that work well together. 

The CRO's project management team contributes significantly to the overall positive sponsor–CRO project team relationship. Yet sponsors were far more likely than CROs to stress the importance of the project management team as a CRO selection criterion. While more than two thirds (68%) of the pharmaceutical company participants stressed this criterion in their selection process, only half (51%) of the CRO respondents thought sponsor companies valued this as very important.

CRO experience. Sponsor companies and CROs placed great weight on a CRO's relevant experience, both in the same indication as the study and in the CRO's overall experience in the appropriate therapeutic area. Sponsor companies and CROs differed somewhat on the importance of a project member's background. While only 45% of the pharmaceutical company participants considered this very important, 62% of the CRO respondents considered it very important to sponsor company decision makers. Sponsor companies seem more interested in the overall cohesiveness of the CRO team members than their vitae. A vitae may be a constructive starting point, but positive sponsor–CRO project team relationship is vital to the project's success. As one pharmaceutical company project manager put it: "CVs can only take you so far. You want to know that the CRO's team fits with the way you want things done and the way you want to work." 

Project execution plan. Another essential criterion (i.e., raised by more than a third of the study's R&D professionals), was the project execution plan. On no other single criterion, though, was there a greater difference between sponsor company and CRO responses. Fifty-nine percent of pharmaceutical company professionals considered the execution plan as fundamental in hiring a CRO; only 28% of respondents from CROs placed the same importance on the execution plan.

Problem solving processes. Sponsor companies are also more likely to value the internal processes CROs use to make appropriate senior CRO managers aware of project problems. Forty-seven percent of the pharmaceutical company participants considered this capability to be essential in selecting a CRO. In contrast, only a third (34%) of the CRO respondents thought it was essential for sponsor companies. 

Other criteria. A smaller number of respondents, from both sponsor companies and CROs, considered the CRO's role as a preferred provider and the CRO's geographic scope to be very important. CRO staff turnover was somewhat more critical to the sponsor companies than many CROs thought was the case. 

Factor analysis only provides a mathematical solution to how the various items relate to each other and how they relate to any underlying dimensions. Factor analysis does not label the individual factors. Items heavily associated with a factor are said to "load on" that factor. Items that load more heavily than others have a bigger explanatory role in understanding the communality of the items associated with that factor. Only a review of the items associated with a given factor can provide a rationale for what the individual items may have in common. 

The individual factors appear in the order of the variance they explain, which is often a function of the number of individual items "loading on" that factor. That order does not necessarily mean that a given factor's explanatory importance is more or less than the factors before or after it. [Table 2 summarizes which of the individual selection criteria load on each factor.]

In this survey, five items load heavily on the first factor, Processes for Issue Identification and Resolution. The individual items all concern the same general issue area: processes used to identify and resolve project and financial issues. Three items are associated with the second factor, the Specifics of Project Execution. Critically, price is inversely related to the other criterion in this factor. The more participants stress the other two items of the factor—quality of the project team and the project execution plan—the less likely they are to emphasize price. Conversely, those who stress price put less weight on the quality of the other items in the factor. The third factor covers the Project Team's Chemistry, including the individuals, their backgrounds, staff turnover rates, and the sponsor company's sense that they can work with the CRO's personnel. Two items, both related to relevant CRO experience, load on the fourth factor: CRO Experience. The fifth factor addresses items associated with a CRO's Capabilities, including the CRO's relationship to the sponsor company. 

The factor analysis provides a score for each individual for each factor. The higher the score for an individual participant on a factor, the more prominent that dimension is to the individual. The relative importance of these five decision-making dimensions differs within key groups involved in selecting and using CROs. For example, sponsor companies and CROs view the importance of one dimension, the Specifics of Project Execution, quite differently. 

As we have seen, sponsor companies value the quality of the execution plan far more in selecting an outsourcing partner than many people in CROs realize. CRO personnel tend to think that price plays a larger role in the selection process than sponsor companies do. There is also one important difference that relates to an organization's size. Participants from the 20 largest organizations, whether they are sponsor companies or CROs, differ from individuals in smaller organizations on one decision-making dimension: CRO Capabilities. 

Larger pharmaceutical companies and CROs give more weight to a CRO's size, geographic reach, and relationship with the sponsor companies. Large organizations, both sponsor companies and CROs, may be more comfortable working with one another as large organizations, especially for bigger studies requiring extensive geographical coverage. 

While Americans stress the mechanics of the CRO/sponsor company relationship, Europeans tend to emphasize more intangibles. These differences by a respondent's geographic location remain significant even when we use ANOVA (analysis of variance) to control for the possible influence of other variables, such as company size and whether a person works for a CRO or sponsor company.

In later research we will examine in more detail the impact of geography in how people approach CRO selection. In addition, we will also present the profiles of companies who do consider themselves better at selecting and managing CROs.

 PhD, is a professor of health policy at the University of the Sciences in Philadelphia and the president of TTC, llc, 4548 Market St., Suite M-20, Philadelphia, PA, 19139, email: 

 MBA, is an associate director at TTC, llc.