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Trials in Developing Countries Pose Legal, Logistical Challenges

February 3, 2009
To ensure compliance with local laws and regulations when conducting clinical trials in developing countries, an expert advises pharmaceutical companies to negotiate a memorandum of understanding (MOU) with the right government ministry and take other steps to minimize risks. A governmental official’s signature on an MOU can be a defense for the sponsor if something goes wrong with the trial and the media raise questions about who approved the study, Mark Barnes of the Huron Consulting Group said.
Clinical Trials Advisor