TY - JOUR
T1 - A critique of emerging European legislation in the pharmaceutical industry
T2 - A clinical trials analysis
AU - Murray, Elizabeth
AU - McAdam, Rodney
AU - Burke, Moira T.
N1 - Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2004
Y1 - 2004
N2 - The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed in relation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.
AB - The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed in relation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.
KW - Clinical medicine
KW - European union information
KW - Organizational change
KW - Pharmaceuticals industry
KW - Research organizations
UR - http://www.scopus.com/inward/record.url?scp=16544369138&partnerID=8YFLogxK
U2 - 10.1108/09526860410563195
DO - 10.1108/09526860410563195
M3 - Article
C2 - 15552394
AN - SCOPUS:16544369138
VL - 17
SP - 389
EP - 393
JO - International Journal of Health Care Quality Assurance
JF - International Journal of Health Care Quality Assurance
SN - 0952-6862
IS - 7
ER -