Wolfgang Schaub, PhD, is a drug development consultant with C.R.O.Cont(r)acts, Luisenstrasse 13, D-65779 Kelkheim, Germany, +49 6195 976 210, fax +49 6195 976 212, email: Wolfgang.Schaub@cro-contracts.com.

Wolfgang Schaub

More than 1000 contract research organizations exist worldwide, and the number is growing. CROs differ widely in size and profile. Before a project can be contracted out, sponsors often spend valuable time searching for the CRO that best fits the project's specifications. Consultants are often needed to help hew a path through this jungle, a task made all the more difficult by the intentional withholding of information that would help sponsors decide. The World Wide Web would be an excellent means for CROs to communicate relevant and fluid information about their companies, and herein I offer a model for CROs to use.		

Figure 1. The structure of the CRO market by scope.	

Since Kenneth Getz and John Vogel wrote a fundamental article, "Achieving Results with CROs: Their Evolving Role in Clinical Development," we have known that "three Cs" should govern the choice of a CRO:

Capability-the CRO can do what the sponsor needs.

Compatibility-the CRO does it in the way the sponsor expects. 

 The process of filtering the best CRO out of a reservoir of more than 1000 calls for first using a coarse-meshed filter, then progressively applying more fine-meshed filters. We focus here on comparing the capabilities of CROs to significantly narrow the field. The other two factors-compatibility and cost-can be explored in subsequent filtering and fine-tuning, possibly also in direct negotiation with a few qualifying CROs.	

 Capability criteria break into four subcategories.	

Scope-Does the CRO carry out the services the sponsor requires?

Geographical reach-Does the CRO operate in a specific region or territory?

Skills-Does the CRO have personnel with the necessary educational background and experience?

Capacity-Will the personnel be available at the time required and in sufficient number?

 Luckily, the current CRO market can easily be structured in terms of scope and geography. As a model it is fair to assume the CRO market breaks into sectors that best can be displayed in the form of pyramids. 	

At the top of the scope pyramid (Figure 1) are a handful of CROs offering a full range of services across the entire area of pharmaceutical development. (Please note that although many CROs claim to offer full service, in reality they do not.) Moving down the pyramid, a few more, say a dozen, CROs offer services only in the clinical area. Most CROs are capable of partial services only-for example, they conduct clinical trials, but do not pack or analyze samples. At the bottom of the pyramid are the niche providers, offering services only in a certain therapeutic area, or a specific methodology, or perhaps only in the form of an electronic application to enable clinical trials. 	

The geography pyramid (Figure 2) is built likewise. A few large CROs have global reach, followed by a number of CROs that claim to be operating globally-but which are in actuality at best moving along on the road toward globality. Roughly 100 CROs operate regionally-that is, on one continent or in several countries. And the large majority of CROs confine their services to one country only-they operate in a geographic niche.		

Figure 2. The stucture of the CRO market by geographical reach.	

In most cases the ranking of a CRO in one pyramid is mirrored by a similar ranking in the other. Asymmetric combinations are possible, however-for example, application providers that offer their systems on a global scale.	

Commercially available directories are reasonably accurate tools for screening CROs for scope and geography. With their guidance, CROs can quickly be sorted as to whether they can perform preclinical, clinical, or ancillary tasks. Within the clinical area, for example, the directory can tell whether a CRO offers protocol design, study setup, study conduct, data management, statistical analysis, medical writing, and/or quality assurance; which clinical phases it focuses on; and whether it has offices in North America and/or Europe, and in which countries?

Our search had originally started with more than 1000 CROs. Applying the filters of scope and geography in most cases brings down the number of potential CROs to something in the area of 100.	

 Here the difficulties begin. Having an office somewhere does not necessarily mean the CRO can carry out the required services from that office. Skilled staff may be located in one continent while required in another. Likewise, staff may be perfectly skilled on the whole, but are they available when the project is to start? Third-party directories can only display static information. Hence they will fail in providing this type of information. 	

It is also important to know in which countries and regions the CRO has already conducted business and when, and what type of business it was. Just because a directory may list the countries a sponsor desires in relation to a given CRO, does that mean the CRO has carried out a service relevant to the subject project in those countries? Again, most directories will not be detailed enough to answer these questions.		

Similarly, directories may provide lists of therapeutic fields in which the CRO has worked previously, but in reality, these lists often reflect the staff's cumulative therapeutic experience, which was not necessarily acquired while with the CRO. Fine, but, how long ago was that experience acquired? And are those personnel still with the CRO? If so, will they be available for the new project?	

Furthermore, directories are expensive and give snapshots; often they are outdated when used.	

The World Wide Web as a fluid source of information

What sponsors really require is a medium that can break down each CRO's staff by educational backgrounds, job roles, time in the present job role, and time employed by that CRO. Also, which languages do these people speak? What are their nationalities? In other words, are they possibly useful for the intended purpose? And are they available for the task required, or are they absorbed in other projects? If they are absorbed in other projects, how long will they remain absorbed? When will they become free?				

It does not help to have CRO skills broken down in a summary table showing only numbers per skill; an individualized presentation is required. Also, because capacity changes rapidly over time, it would be useful to view the dynamics of this change. A tabular display in a static paper format, like in many directories, is obviously not the medium of choice.	

A solution can be found in the World Wide Web. The Web is a flexible medium that can be used for free. If it were continually fed with the required information, it could well be quite helpful. So let us examine the Internet's current and potential use.	

 Web designers have indoctrinated us as to how "well-designed" Web sites should look. Essentially, Web sites should 	

attract interest (colors, paintings, animation, flashes).

provide brief information ("what we do," "about us").

Web sites typically appear to be meant for the quick surfer, the young kid, the "easy" generation, the computer addict. Upon screening the home pages of CROs, one realizes they all follow this pattern in one way or another. One is overwhelmed with fantastic pictures, inflated statements everywhere, and-big disappointment! Nowhere is the required information that tells which skills are available, where, and when. Deplorably, CRO Web sites fail completely in responding to serious sponsor interests. The larger the CRO is, in fact, the less detail can be expected on its Web site. 	

The following typical statements are taken from some CRO Web sites:		

"We build long-term business relationships through our proven project delivery systems and dedication to customer satisfaction."	

"With a commitment to quality, our professionals ensure that your needs are met. You have a consistent, dependable point of contact who gives you access to the entire range of capabilities. Your team ensures that the right tools are used in order to move you efficiently through Phases II and III and beyond."	

"We take innovative approaches to provide that clean, high-quality data are generated on time and within budget by challenging assumptions about traditional clinical trial design and management."	

"We are recognized in the market for our enthusiasm, dedication, attention to detail, and flexibility. Whether a single service or complete management package, you can rely on us to provide you with a personal service of the highest quality both nationally and internationally."	

Statements of that sort are as nice as they are entirely useless.	

In short, the current World Wide Web presentation of CROs is inadequate to facilitate a choice. The wealth of utterly meaningless statements poured over the reader do little to help a sponsor condense the spectrum of CROs from "potentially appropriate" to "optimal." The step from 100 to 1 has to be made in complete darkness. Vital information is missing. One begins to wonder if the CROs' Web presentations are good for any purpose at all.	

 Working with CROs is serious business. CROs often complain about the time and effort they spend in receiving and entertaining sponsor visitors for live presentations-without business directly resulting. CROs complain about the high number of proposals they have to prepare and the low "hit rate." Should they not anticipate more efficiently what their clients really want to know and put that on their Web sites? Shall one conclude CROs are not mature yet?	

Here is a proposal up for discussion: CROs may carry on with their glossy Web sites, but they should add subpages for the serious reader. These should ideally be standardized to enable efficient comparison across the competition. This might be a task for a CRO panel to implement-is there such a panel somewhere? Can POMA-the Pharmaceutical Outsourcing Management Association-act as a panel?

Such subpages should include summary tables on numbers of persons (full-time equivalents, FTEs) in each category. The table, Staff Composition Summaries, shows some suggested formats. Furthermore, each relevant individual should have a page of information in a standardized, anonymized presentation, attached to key terms that allow searching for specific personal profiles, skills, and availability. A format is proposed in the Capability Summary Page. The information would be cross-linked, so that the summary tables would automatically compose on the dynamic basis of the individual personalized sheets. All this would be accessible to potential clients, and possibly password-protected. 	

All it would require in each CRO is a person who continually updates the information in the individual personalized sheets. No longer would the poor business development manager have to make solicitous phone calls to presumed sponsors and disgracefully have to beg for business. No longer would sponsors, in search for CROs, have to listen to marketing presentations of little value. Suddenly, the concept of business development would be meaningful.	

And more information could be added to CRO Web pages, such as ratio of full-time to part-time employees, number of free-lancers working for the CRO, number of currently ongoing projects, number of projects each person is dedicated to, number of persons who had to quit the CRO in the previous calendar year, versus number hired, and on top of it all: Which is the superior capability by which the CRO believes it excels? Three words only, please.	

Too much to ask? If all this information would be available at a mouse click, the choice of CROs could be optimally tailored to project specifications. One day sponsors would find their dream CROs simply through the Internet. One day CROs would only attract work in fields with which they are reasonably familiar, and at appropriate times. One day consultants would become superfluous in helping find CROs for sponsors. 				

One day that mysterious intransparency that surrounds CROs today would disappear. Many CRO executives still seem to have a strange interest in preserving that intransparency. They appear to be afraid that concise information may keep clients away or drive them to the competition. The consequence is that these CROs catch business at random, and it is often business they can only poorly handle. So sponsors continue tumbling from one frustration to the next.	

Articles

More than 1000 contract research organizations exist worldwide, and the number is growing. CROs differ widely in size and profile. Before a project can be contracted out, sponsors often spend valuable time searching for the CRO that best fits the project's specifications. Consultants are often needed to help hew a path through this jungle, a task made all the more difficult by the intentional withholding of information that would help sponsors decide. The World Wide Web would be an excellent means for CROs to communicate relevant and fluid information about their companies, and herein I offer a model for CROs to use.

Wolfgang Schaub

Articles

Searching for a CRO - Can the Internet Help?