title: Clinical research strategies in biotechnology.
abstract: Clinical drug development involves many steps and is extremely costly to the sponsoring company. There is intense pressure on sponsors to be faster, more efficient, and less costly. Sponsors also need to be globally oriented in their drug-development processes. There are several ways in which clinical drug development may be done more quickly and at less cost. These strategies include the use of large contract research organizations (CRO) and site management organizations (SMO). Although there is an estimated 2000 CRO worldwide, the use of SMO is quite limited but growing rapidly. Changes in the US Food and Drug Administration (FDA), especially harmonization between its two divisions Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), and the use of CRO and SMO will make for interesting and challenging times for sponsors.
authors.affiliation: Amgen Inc., Thousand Oaks, California 91320-1789, USA.
authors.forename: M
authors.initials: M
authors.lastname: Vincent-Gattis
authors.forename: C
authors.initials: C
authors.lastname: Webb
authors.forename: M
authors.initials: M
authors.lastname: Foote
mesh_terms: D001688:Biological Products / Q000494:pharmacology*; D001709:Biotechnology / Q000379:methods*; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D015507:Drugs, Investigational; D006801:Humans
chemical_list: D001688:Biological Products; D015507:Drugs, Investigational