CHICAGO, Aug. 13 /PRNewswire-FirstCall/ -- As biotechnology, pharmaceutical and medical device companies increasingly move clinical trials beyond their own borders to other parts of the world, such as Asia, Eastern Europe and South America, complicated regulatory environments challenge those firms' efforts to do business, according to an analysis by Aon Corporation (NYSE: AOC). Aon's 2008 Clinical Trials Risk Map provides those companies a visual representation of the complex insurance requirements and risk management needs that exist for companies conducting clinical trials internationally.
A robust research and development pipeline is essential to bringing new drugs or medical products to market, with clinical trials being an important step in the process of regulatory approval and marketing. While companies find benefits to conducting trials abroad, insurance and risk management requirements vary. Missteps in the placement of insurance can delay or disrupt clinical trials, resulting in costly financial implications for the life sciences company.
In 53 percent of the countries included in Aon's analysis, businesses must include a certificate of insurance in their regulatory filing package. Additionally:
-- Certificates issued by locally licensed insurance companies are generally required for regulatory filings, and most countries' regulatory authorities have specific requirements for insurance certifications.
-- Turnaround time for certification issuance is often longer, particularly when local admitted insurance companies must be used.
-- Delays or errors 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 Requirements with Successor Liability Requirements" (specific regulatory requirements also require coverage for a period of time following the conclusion of the trial).
Produced by Aon Risk Services' Life Sciences practice group and the Aon
Global Client Network, the map drew its information from a survey of the
Aon Global Client Network in 71 countries to determine the regulatory and
ethics committee requirements for Clinical Trial insurance. This
information is housed in a proprietary database that is updated as
To request a copy of the map, visit: http://aon.mediaroom.com/index.php?s=63&item=260.
About Aon Corporation
Aon Corporation (NYSE: AOC) is the leading global provider of risk
management services, insurance and reinsurance brokerage, human capital and
management consulting. Through its 36,000 colleagues worldwide, Aon readily
delivers distinctive client value via innovative and effective risk
management and workforce productivity solutions. Our industry-leading
global resources, technical expertise and industry knowledge are delivered
locally through more than 500 offices in more than 120 countries. Aon was
named the world's best broker by Euromoney magazine's 2008 Insurance
Survey. In 2008, Aon ranked highest on the Business Insurance ranking of
the world's largest insurance brokers based on commercial retail,
wholesale, reinsurance and personal lines brokerage revenues. Aon also was
ranked by A.M. Best as the number one insurance broker based on brokerage
revenues in 2007 and 2008, and was voted best insurance intermediary, best
reinsurance intermediary, and best employee benefits consulting firm in
2007 by the readers of Business Insurance. For more information on Aon, log
Elly Krumwiede Rahsaan Johnson
(1) Berndt, E.R., Sinskeyy, A.J., Theirs, F.A. Trends in Globalization of
Clinical Trials. Nature Reviews: Drug Discovery [online]. November
|SOURCE Aon Corporation|
Copyright©2008 PR Newswire.
All rights reserved