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International Clinical Trials
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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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