Aon eSolutions launches clinical trials
Aon eSolutions, the client technology arm of Aon Corporation (NYSE: AOC) and the leading provider of global risk and insurance solutions, today announced it has launched a new Clinical Trials module as part of RiskConsole, the market-leading, browser-based risk management information system (RMIS).
Developed in conjunction with the Life Sciences practice of Aon Risk Services, RiskConsole's new Clinical Trials module enables risk managers to monitor all of the clinical trials in which their organizations are involved, the total exposures represented by those trials, and the required insurance coverage. At the same time, RiskConsole enables organizations to streamline the management of clinical trials, providing visibility into project status across studies.
Clinical trials and clinical research is the process of testing the safety and efficacy of new drugs and medical devices before they're approved by the U.S. Food & Drug Administration. General and professional liability coverage is required throughout this testing process. As a result, sponsoring pharmaceutical and life sciences companies, as well as participating healthcare facilities and professionals, need to carefully track, assess, and manage clinical trial risks in order to obtain adequate coverage.
"Risk managers may find it challenging to keep track of the many clinical
trials taking place at their institutions, and obtaining an overview is
time-consuming and resource intensive," said Kathleen Burns, chief executive
officer of Aon eSolutions. "With RiskConsole, risk managers have the ability
to monitor clinical trials worldwide, so they have an immediate and comprehensive understanding of the trials underway and the extent of the exposure."
Increased globalization of clinical trials presents additional challenges for life sciences companies. Aon's 2008 Clinical Trials Risk Map charts the complex insurance requirements and risk management needs that exist for companies conducting clinical trials globally. For instance, in 53 percent of the countries included in Aon's analysis, businesses must include a certificate of insurance in their regulatory filing package.
The RiskConsole Clinical Trials module tracks coverage required by government
agencies in various host countries, and whether proper insurance documentation
was provided to regulators. The system also acts as a valuable planning tool
that enables companies to better manage the entire life cycle of a clinical trial. Other key features and benefits include:
-- The ability to track certificates of insurance and T85 protocol
documents electronically.
-- Time-stamping enables risk managers to monitor and determine the
current stage and ongoing progress of trials.
-- A user-friendly graphical dashboard identifies when critical
milestones are met.
-- Multi-currency, multi-lingual capabilities accommodate the need to
monitor clinical trial exposure worldwide.
-- Automatic scheduling of reports and distribution of alerts to notify
companies of potential problems, adverse events, or non-compliance.
-- Real-time coordination of communication and activities among various
stakeholders, including the risk manager, researchers, project
managers, clinical directors, brokers, and underwriters.
"Clinical trials are essential to bringing new drugs or medical products to market, but missteps in the placement of insurance can delay or disrupt the process, resulting in costly financial implications," said James Walters, managing director of Aon Risk Services' Life Sciences practice group. "To date, companies used paper-based processes and spreadsheets to track clinical trials. RiskConsole offers a web-based platform to streamline this process and ensure proper coverage has been secured."
