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International Clinical Trials

Protected Planning

According to the National Institutes of Health, a division of the US Department of Health and Human Services, there are currently more than 58,000 trials taking place in more than 150 countries. In addition, clinical trials have been relocating from Europe and the US to emerging markets such as India, China, Vietnam and South America. Moving to new regions has helped trial sponsors reduce the costs of conducting trials as well as recruit participants from new pools of patients.

One of the main challenges that life science companies face, however, is keeping abreast of the various insurance requirements imposed by these counties. Companies with multinational trials must juggle a myriad of various regulations regarding policy terms and conditions, which include issues such as discovery period, run-off phase, capacity limits and liability levels. In some cases, life science companies may need to secure a different policy for each host country.

Securing appropriate clinical trial insurance, especially for multinational studies, can be costly and logistically difficult to manage. Many factors must be taken into consideration early in the trial planning process. Otherwise, sponsors may find out too late that coverage in a certain region is prohibitively expensive or would take too long to secure a local policy. Missteps in the placement or certification process could delay or disrupt trials with far-reaching financial implications. In this article, we discuss the role that integrated insurance expertise and web-based technology can play in streamlining the clinical trial insurance process.

TRIAL INSURANCE: A FAST-MOVING TARGET

Although most trial sponsors would not consider launching a study without first obtaining clinical trials insurance, it isn’t always a prerequisite. Many countries require it in a sponsor’s regulatory filing package, though some do not. Of the countries that mandate it, some accept certificates of insurance from a foreign-based insurance policy, while others demand certificates from a locally licensed carrier, which must be written in the local language. Needless to say, clinical trial insurance is a fast-moving target with mandates varying by country and frequently changing.

Producing insurance certificates establishes that a company has the coverage to indemnify and pay the medical bills for trial participants should they claim that the study allegedly caused harm. Securing certificates can be a time-consuming and complex process. The turnaround time can take longer when locally admitted insurance companies are used. Delays or errors in certification can consequently hold up regulatory filings and approvals by government agencies.

The last thing a company wants is for the insurance requirement to hold up the clinical trial. Every day that is wasted translates into lost opportunity for the sponsoring company. By some estimates, a company can potentially lose $3 million a day when a blockbuster drug spends extra time in development. The goal is to quickly identify the required coverage, decide when it must be in place and how much is required, and to make the procurement process as efficient and seamless as possible.

BROKERS: HOW TO TAKE AIM

When working towards the goal of adequate coverage, life science companies must realise that clinical trials insurance is not a commodity; it is sophisticated coverage that requires specialised knowledge and counsel. By partnering with the right brokerage firm, companies can keep abreast with the latest clinical trial insurance requirements. It is important to utilise a firm that has a comprehensive and integrated approach, which includes a worldwide network of offices, operations in popular host countries, an understanding of local trial requirements and rapid issuance of insurance certificates.

With the right partner, trial sponsors benefit from expert services in identifying the right carrier and insurance products; negotiating the best coverage terms and conditions; and gaining access to sophisticated web-based technology that automates, streamlines and expedites key risk and insurance management processes.

Today, an expert brokerage firm will have a proprietary database outlining the regulations and market practices for clinical trials insurance in more than 100 countries. As a result, the brokerage firm will be well versed in local regulatory requirements. A specialised firm will also provide clients with a clinical trials risk map, which geographically catalogues and continually updates insurance requirements by region. This map can help life science companies in their planning when looking to identify trial sites, recruit patients, project budgets, as well as plan for other locally mandated requirements. All these factors help to ensure that life science companies have the right expertise and coverage in place.

WEB-BASED TECHNOLOGY: HITTING THE MARK

In the past, paper-based insurance processes created delays and inefficiencies in the clinical trials insurance process. In recent years, a browser-based risk management information system (RMIS) can act as a global platform that streamlines operations. It is designed to provide companies with an enterprise-wide view of clinical trial information with multilingual, multi-currency capabilities. At the same time, a RMIS can help cut development costs and reduce a company’s ‘time to market’ by streamlining key steps in the clinical trials insurance process.

Insurance Submissions
Underwriters are now demanding more detailed clinical trial information. Risk managers can leverage a browser-based RMIS to gather and submit advanced data that is required, such as trial location, number of participants and trial dates. Companies can also differentiate themselves by providing information that shows good loss experience and exemplary patient safety standards. The better the information, the better leverage companies will have in the marketplace to optimise insurance costs and coverage.

Certificates of Insurance
General, professional and product liability insurance coverage may be required prior to trial launch, as well as throughout the numerous phases of the clinical trial. At various stages, sponsoring companies must distribute insurance certificates to the right regulatory agencies and ethic committees. A RMIS tracks the insurance requirements in various host countries, and whether proper insurance documentation was provided to regulators within an appropriate timeframe. With automated tracking and scheduling capabilities, the time and effort required to obtain certificates is reduced dramatically.

Streamlined Workflow
In the past, clinical trials relied on paper-based forms and spreadsheets, which were not dynamic or secure. Today, a web-based RMIS enables electronic data capture and transfer via the internet. This ensures quality data and real-time sharing of information, which further streamlines the management of clinical trials. In fact, delays in initiating and executing clinical trials due to poor record management and planning are virtually eliminated when a RMIS is used.

Centralised Data Repository
In the past, having a trial master file was an elusive goal. Typically, the master file included ‘essential study documents’, such as brochures, protocols and informed consent forms. Traditionally, this information was stored in binders and could amount to more than 10,000 individual documents, which made it extremely difficult to manage because information was not electronically stored or consolidated. A browser-based RMIS enables companies to create a centralised data repository for these documents to be electronically accessed and shared. This provides a substantial saving by reducing paper documents and manual processing. Instead, through the web-based platform, companies can view clinical trial information holistically – which is instrumental to timely and efficient start-up and ongoing trial progress.

Improved Communication
A web-based RIMS fosters connectivity among key stakeholders across the globe and eliminates traditional silos of information among countries, R&D, safety, clinical research organisations, and other clinical trial professionals. This helps to improve communication and collaboration among all parties involved in the clinical trials risk and insurance process.

Reporting & Analysis
Obtaining a consolidated overview of a company’s clinical trial was previously a resource-intensive task. A RMIS enhances data reporting and analysis, giving a complete and immediate understanding of the trials being undertaken and the extent of the exposure. In essence, today’s RMIS provides a wider perspective on clinical trials, enabling companies to manage risk and insurance requirements across their company and with more control than ever before.

FUTURE GOALS: SPEED & EFFICIENCY

With mounting discovery and development costs, life sciences companies can no longer wait for a blockbuster breakthrough, nor can they afford to have insurance requirements hinder speed-to-market efforts. A more integrated approach between insurance expertise and information management is required – one that is collaborative and consolidates information to make the process more efficient and transparent. Most life science companies need an insurance programme that will keep pace with their future plans for growth and product expansion. Traditionally, companies relied on disjointed communication and planning that included email requests and spreadsheets to share clinical trial information.

A RMIS enhances day-to-day administration of clinical trials. Since it is web-based, authorised users can log on to view the current status of studies. Streamlining the procurement and proof of insurance are critical to ensuring companies can quickly get through the clinical trial and regulatory approval process. The faster they can get through these steps, the faster they can reap the benefits of bringing that product to market.


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Kathy Burns brings 20 years of experience in risk and insurance technology to her role as CEO of Aon eSolutions, the technology-solutions unit of Aon Corporation. Under Kathy’s leadership, Aon eSolutions has successfully integrated Aon’s worldwide technology-solutions business. Kathy has also led the successful acquisition of Valley Oak Systems, a US provider of claims-administration systems. Prior to joining Aon, Kathy was responsible for global operations for a large insurance-technology firm. In that role, she led the successful integration of two acquired businesses. Email: kathleen.m.burns@aon.com
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