[PDF] Putting Contract Research Organisations on the Radar: An exploratory study on the outsourcing of clinical trials by pharmaceutical companies to contract research organisations in non-traditional trial regions

Author: Mariëtte van Huijstee & Irene Schipper, SOMO, Salud y Fármacos, Centre for Studies in Ethics and Rights, Published on: 1 February 2011

The ultimate goal of this study is to persuade all the actors…to take responsibility to protect the human rights of clinical trial participants in non-traditional trial regions…[A]ccording to international regulations, pharmaceutical companies remain formally responsible for the ethical conduct of the trial they sponsor. This is in sharp contrast to other sectors…the sector needs to be greatly improved…The major global pharmaceutical companies were invited to participate in a research on the ethical risks associated with outsourcing and offshoring. This included Abbot, AstraZeneca, Bristol Meyers Squibb, Eli Lilly, GlaxoSmithKline (GSK), Janssen (the pharmaceutical division of Johnson & Johnson), Merck/MSD, Novartis, Pfizer-Wyeth, Roche and Sanofi-Aventis. After a lot of persuasion, six companies finally agreed to participate…As a last step in the research process, a review of a draft of this report was organised, involving…the pharmaceutical companies that participated in the research. Their comments have been integrated in the final version of this report...a total of ten CROs were interviewed [also refers to AAIPharma, ACLIRES International, Actelion, Amgem, Astellas, Astra Zeneca, Bayer, Boehringer, Biogen, Charles River Laboratories, Chiltern, Covance, Curetech, Daiichi Sankyo, Eurotrials, Genentech, Genexion, ICON, I3 Latin America, Kendle International, NIH, Novartis, Otzuka, PAREXEL, Pharmaceutical Product Development, PharmaNet Development Group, Phenomix, PRA International, Quintiles Transnational Corporation, Sanofi, Schering Plough, Takeda Global Research, Tibotec, INC Research, Ingenix, MedPace, Omnicare, Oncopartners, Pharm-Olam Serviços Clinicos, Progenitor, PSI, RPS, Siplas Research Organisation, World Wide Clinical Research, ECLA, HRPC, Intrials, Vigium, Abel Santos, Activa CRO, Blancahrd y Associados, DS Consult, EGCP, Gonzalez Asociados Pharma Consulting, Gotuzzo Asociados, Grupo Jasovich, HMED – Distributor of medical supplies, INMENSA, IMPACTA, Investigación Clínica Asociada, IPCSP, Klixar, Latinamerican Research, Latinclin, M Matiss, Newco Trials, Panamerican Medical Supply, Peruvian Clinical Research, PHC Pharma Consulting, PGS Medical Statistics, QUID consultora, RD Lantam]

Read the full post here

Related companies: Abbott Laboratories AstraZeneca Bristol-Myers Squibb Daiichi Sankyo Eli Lilly GlaxoSmithKline Janssen Pharmaceutica (part of Johnson & Johnson) Johnson & Johnson Merck Novartis Omnicare Pfizer Roche Sanofi Wyeth (part of Pfizer)