Contract Research Organizations &
Vendor Appraisals

Increasing requirements in terms of study complexity, human resources and material, as well as tighter than ever competition, and the restructuring of research and development (R & D) away from classical chemistry towards molecular modeling and other modern and more productive technologies, have made it necessary for the pharmaceutical industry, and more specifically, clinical development to focus on those areas that can best be carried out with internally available resources, and to contract out or “outsource” the rest (outsourcing = outside resource utilization).

It is true that the CROs have been accustomed from the outset to costing all sorts of items, and since they earn their living directly from what they do, their costing is bottom-up and therefore more accurate (many a times).

CROs can create immense value because they are ready to start work immediately. If this value is expressed in terms of time saved to market, its case equivalents can be higher by many factors than the price charged by the CRO. For example, a study may cost USD 5 million; if time-critical, contracting out this study may save one year of development time for the product. Over the entire product life cycle, being on the market one year earlier than the competition may generate USD 100 million of additional profits.

See this in light, it is of little importance whether the study costs USD 5 or 6 million (Schaub, 2000). Moreover, differences in the prices quoted by competing CROs place into insignificance when compared with the potential value of working with a CRO. A Sponsor, who has received offers from two CROs and takes 2 weeks to evaluate them, will lose more than the price difference between CRO 1 and CRO 2.

In conclusion, the CRO selected should be the one that offers the best technical, scientific and geographical capability to carry out the project and that has the best possible people to handle the task. Price is a relatively minor factor among the selection criteria, and sponsors should not spend more time than absolutely necessary in analyzing prices charged by CROs. Analysis should instead focus on the activities that make up the price. A first-class service inevitably costs more, but high-quality products (data) make their way through the regulatory channels more easily than dubious, possibly deficient material.

The lesson is that, tactical outsourcing saves time (while the CRO is working, in-house staff can address other issues) and generates additional values.

We at Consortium Clinical Research assist and guide our clients with our expertise, in making the critical decisions of selecting their ideal partners be it a CRO or different vendors like the laboratories, courier agencies, data management centres, etc., to ensure that their clinical trials are conducted as per the statutory requirements while maintaining the precious time limits under control too.

Information has been resourced from Principles of Clinical Research, 2001.