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Aon: Complex Insurance Requirements, Risk Management Needs Challenge Firms Conducting Clinical Trials Beyond Own Borders
Date:8/13/2008

rrors in certification can result in delays in regulatory filings and approvals by ethics committees, ministries of health and other oversight authorities.

"Our analysis provides an overview of the constantly changing clinical trials landscape," said James Walters, managing director of Aon Risk Services' Life Sciences practice group. "Conducting clinical trials globally is an increasingly popular practice for firms seeking to bring better medicines and therapies to market, and insurance is the last thing that should stand in the way of the life sciences research so critical to human health and disease management."

To enable companies to better monitor clinical trials worldwide, Aon has developed a new Clinical Trials module as part of its risk management information system, RiskConsole. To date, companies used paper-based processes and spreadsheets to track clinical trials and coordinate coverage. RiskConsole offers a Web-based platform to manage the clinical trials process and ensure necessary insurance is secured.

Aon's report found that China, Estonia, Russia, Peru and Malaysia have been experiencing the most growth in the number of clinical trial sites. In China alone, the number of clinical trials grew by 47 percent in 2006.(1) And with the exception of Peru, each of these countries requires locally admitted insurance. Russia has a limited local market for clinical trials insurance, which presents an even greater challenge to the life sciences company seeking to expand their clinical trials into this country.

About the 2008 Clinical Trials Risk Map

Aon identified and plotted the regulatory risks of 71 countries on the 2008 Clinical Trials Risk Map. The insurance requirement in each country was noted as:

-- Green - "No CT Requirements" (no specific regulatory or ethics committee requirements);

-- Yellow - "CT Requirements" (specific regulatory or ethics committee requirements); or

-- Orange - "CT Requiremen
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SOURCE Aon Corporation
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