Contract research organizations (CROs) may be the next trend in clinical trials liability.
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.
Valdes
Sonia
S
Chubb & Son, USA.
McGuire
Penny
P
D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards; D003284:Contract Services / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D007221:Industry; D016365:Liability, Legal; D012308:Risk Management / Q000331:legislation & jurisprudence* / Q000458:organization & administration*