ABSTRACT
I. Introduction.......................................................................................... 315
II. What is a CRO?................................................................................... 316
III. Importance of CROs in Pharmaceutical Clinical Research................ 317
IV. Why do Pharmaceutical Companies Use CROs? ............................... 320
V. The Role of the Statistician in CRO Activities .................................. 321
References........................................................................................................ 323
Contract Research Organizations (CROs) have played an increasingly important
role in pharmaceutical research over the past decade. The role of these
organizations within the pharmaceutical industry and their interactions with
pharmaceutical companies in development of new drugs have been discussed in
this chapter. CROs are defined in accordance with the services they provide and
in terms of the organizational structure. The importance of CROs is then assessed
by the amount of work they do in support of the clinical research activities
by pharmaceutical companies. The underlying reasons for engaging CROs by
the pharmaceutical companies and the role of statisticians in CROs keeping
the statistical applications requirements in pharmaceutical industry in view are
discussed from two different perspectives, viz., the role of statisticians in
the pharmaceutical industry in interfacing with a CRO, and the role of CRO
statisticians in performing necessary work within their own organizations as
well as in interfacing with the client companies.
