A large portion of clinical research projects are being carried out by contract research organisations (CROs) on behalf of the pharmaceutical industry, and the proportion is growing.
More than 1000 CROs exist worldwide and their number is growing likewise. CROs differ widely in what they can do, where and how they do it and with which resources.
Before a project is contracted out, sponsors spend valuable time searching for the CRO that best fits the project's specifications. Most sponsors have searched for ways to shorten this unproductive run-in process, have limited the circle of CROs with which they co-operate to a small number of apreferred' or otherwise generally appropriate ones, and challenge this selection occasionally against a benchmark of CROs that normally stand outside of the inner circle. This strategy, over the years, has proven best policy for most pharmaceutical companies.
There are, however, myriads of start-up companies, mostly in the biotech sector, which all have to start from scratch. Where, in the pool of over 1000 CROs, is the best for the project? Is CRO one best for project one also best for a different-in-scope project two? What carries most value: the expertise, the speed, the quality, or simply the mechanical ability to manage a massive data acquisition on large scale? As criteria may vary from case to case, the selection process for the best CRO may have to be repeated project by project.
This selection process is not a matter of science; nevertheless it requires professional insight, and pitfalls and errors along the way massively influence the timely outcome, quality and overall success of a project. It must therefore be in the interest of the project managers concerned to know which filters to apply to arrive, project for project, at the best possible CRO.
The three Cs
Fishing in a reservoir of over 1000 obviously calls for using coarse-meshed filters first, then progressively applying more fine-meshed filters. All filters have something to do with the athree Cs'1: u Capability the CRO can do what I need. u Compatibility the CRO does it in the way I expect. u Cost.
As a consultant I recommend looking at capability first. Capability breaks down into four subcategories: u Scope does the CRO carry out the services I require? u Geographical reach does the CRO operate in the desired region or territory? u Skills does the CRO have personnel with the necessary educational background, experience or even expertise? u Capacity will the personnel be available at the time required and in sufficient number?
Let us begin with scope first. The CRO market is structured in scope sectors, like a pyramid (Fig.1).
At the top of the scope pyramid are a handful of CROs offering a full range of services across the entire area of pharmaceutical development (many CROs claim to offer full service, although 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 analyse samples.
At the broad 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.
Commercially available directories are excellent tools for this first screening step2. 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, directories 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.
The geography pyramid is built likewise (Fig.2).
A few large CROs have global reach, followed by a number of CROs that claim to be operating globally but which are actually 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 geographic niches.
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.
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. We need to filter more finely.
Skills and capacity
Still within acapability' we look now for the skills offered and in which capacity. 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 fail to provide information in this respect; they can only display static information. Hence they will fail in providing further help. What is required is a dynamic information medium.
It is also important to know in which countries and regions the CRO has already conducted business and when, and also what type of business this was. Just because a directory may list countries in relation to a given CRO, does that mean the CRO has carried out a service in those countries relevant to my project? 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 often had been acquired off-CRO. How long ago was that? And are those personnel still with the CRO? If so, will they be available for my project?
Furthermore, directories are expensive and give snapshots; often they are outdated when used. Directories that take the price charged for a service as a lead criterion are of limited use either, since aprice' may be inversely related to cost: cost is price plus transaction expenditure, and only acost' that includes all transaction expenditure is a relevant criterion.
Information on the web
The World Wide Web would be an excellent means for CROs to communicate relevant and fluid information about their skills and capacity. What sponsors really require is a medium that makes transparent: 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 for my project?
Current CRO websites typically carry statements that are as nice as they are utterly useless. In contrast, if CROs continually fed their sites with the required information, they could well become useful tools in a search process. I view this an enhanced role for business development instead of annoying potential clients with undesired telephone calls.
As long as this residual intransparency remains, the step from 100 to one, if not done in complete darkness, has therefore to be made by visiting and examining some CROs in person. As a clinical project manager I want my projects to be good, fast and cheap in precisely that order. Here is the chance to directly inspect CROs and interview relevant personnel, having the following secondary criteria in mind.
The first is quality. Quality must stand in the first place because if rubbish is produced, time will be lost and cost wasted to such an extent that it may kill a project. Second is speed. Speed plays a significant role in competitive scenarios, and even if not coming to the market early will generate immense value. The third is price. The price charged should reflect the value generated, and the add-on costs caused by managing the CRO should be minimal. Anyway, if a CRO can satisfy all requirements, the price turns out the least important selection criterion.
Congratulations to the winner!
Wolfgang Schaub, PhD, is Clinical Outsourcing Consultant with C.R.O.Cont(r)acts, Luisenstrasse 13,
D - 65779 Kelkheim, Germany, tel +49 6195 976 210, fax +49 6195 976 212, email Wolfgang.Schaub@cro-contracts.com