Valdes Sonia, McGuire Penny
Chubb & Son, USA.
J Biolaw Bus. 2004;7(3):11-5.
Pharmaceutical companies, medical device manufacturers and other biotechnology firms face increasing financial pressure as research and development expenses rapidly rise, mostly because of the need for longer, larger and more complex clinical trials. This environment creates valuable outsourcing opportunities for contract research organizations in traditional clinical research and an expanding variety of other services. But as contract research organizations (CROs) assume more responsibilities for conducting clinical trials, they may also be assuming liability risks for injuries to participants and for financial losses that may delay the regulatory approval process for a product. This article provides an overview of risk management strategy with an analysis of potential liabilities and establishes steps that may help minimize these risks.
随着研发费用迅速上升，制药公司、医疗设备制造商和其他生物技术公司面临着越来越大的财务压力，这主要是因为需要进行更长时间、规模更大且更复杂的临床试验。这种环境为合同研究组织在传统临床研究及各种其他不断扩展的服务领域创造了宝贵的外包机会。但是，随着合同研究组织（CRO）承担更多进行临床试验的责任，它们可能也在为参与者受伤以及可能延误产品监管审批流程的财务损失承担责任风险。本文概述了风险管理策略，分析了潜在责任，并制定了有助于将这些风险降至最低的步骤。
