Research Organizations &
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).
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).
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.
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.
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.
lesson is that, tactical outsourcing saves time (while the CRO is
working, in-house staff can address other issues) and generates
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.
has been resourced from Principles of Clinical Research, 2001.