Aon: Complex Insurance Requirements, Risk Management Needs Challenge Firms Conducting Clinical Trials Beyond Own Borders
13 Agosto 2008 - 8:30PM
PR Newswire (US)
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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20041215/CGW049LOGO) 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 regulations
change. 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
onto http://www.aon.com/. Media contacts: Elly Krumwiede Rahsaan
Johnson 312.729.4258 312.381.2684 (1) Berndt, E.R., Sinskeyy, A.J.,
Theirs, F.A. Trends in Globalization of Clinical Trials. Nature
Reviews: Drug Discovery [online]. November 2007.
http://www.newscom.com/cgi-bin/prnh/20041215/CGW049LOGO
http://photoarchive.ap.org/ DATASOURCE: Aon Corporation CONTACT:
Rahsaan Johnson of Aon Corporation, +1-312-381-2684, ; or Elly
Krumwiede, +1-312-729-4258, , for Aon Corporation Web site:
http://www.aon.com/
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