Clinical Trials Insurance Liability Brochure - Allianz Global ...

Clinical Trials Insurance
Global solutions for clinical trials liability

Specialist cover for clinical research.
Global Partnership for Global Trials
The challenges of international clinical research are now increasing
faster than ever. Pharmaceutical companies and research
organisations face increasingly complex worldwide regulations
alongside other challenges such as trial safety, speed and quality.
The opportunities presented by emerging clinical trial locations are
balanced by the need for local support and knowledge, with an
absolute requirement for reliable service in these new territories.
Allianz Global Corporate & Specialty
recognises the complexity of today’s clinical
research environment. Our dedicated Clinical
Trials underwriters, working in partnership
with clients and their brokers, offer specialist
insurance services to cover trials around the
world, from single studies to multi-location
research programs.
Backed by the unique combination of Allianz’s
international network and robust financial
security, we offer tailor-made flexible products
for the clinical trials industry, delivered locally
but coordinated centrally through your
primary entry point for Allianz Global
Corporate & Specialty at your location. With an
established reputation and proven
capabilities, Allianz Global Corporate &
Specialty is committed to developing long
term relationships with clients and brokers
throughout the Clinical Trials sector.
Allianz Global Corporate & Specialty Clinical Trials
cover provides:
• Indemnity to the insured as “trial sponsor”,
including pharmaceutical companies and
contract research organisations
• Liability for injury to a trial participant, including
no-fault compensation where required
• Coverage is provided for the full length of the trial

Tailor-made solutions
for individual needs.
No clinical research program is the same as
another - so we at Allianz ensure that each
client’s needs are specifically reflected in the
coverage offered. Our underwriting teams –
which include pharmaceutical experts – work
closely with the client and their brokers to
establish the exact coverage requirements in
each case. So whether it is for a single trial or for
the most complex trial programs in multiple
territories, we can offer tailor-made solutions to
fit the client’s needs.
• Cover for clinical trials with drugs
(from Phase I to IV) and medical devices
including non-compulsory studies
• The Allianz cover is generally provided on
a local basis in every territory in which
trials are performed
• We offer a large underwriting capacity
regardless of the number of trials
undertaken by an individual client –
so we can accommodate clients with
large clinical trial programs
• No fault compensation is offered
where required
• Local policies are generally provided in
local languages
• All policies are in line with local statutory
limits and coverage
• For clients performing a limited number
of trials, policies can be provided on an
individual stand alone basis or as part of a
global program
In Practice - example coverage.
ABC plc – a mid sized pharmaceutical company - is now embarking on
Phase 3 trials to evaluate the safety and efficacy of ABC’s new
investigational product “ABC-993”. Trials are planned over a 10 month
period in 7 territories including Asia and Eastern Europe. ABC requires:
• Local language fully admitted policies in each territory
• Compliance with the local level of cover in all territories
• Rapid delivery of documentation to comply with the trial submission
dates at each location
The Allianz Solution
Allianz Global Corporate & Specialty and ABC’s broker discuss the specific
requirements of the trial and how Allianz can provide the best possible
cover:
• Individual per trial cover is underwritten and quoted for by Allianz
Global Corporate & Specialty
• Local Allianz offices are engaged to provide the fully compliant local
policies to ensure the clinical trials can proceed without delay
• Global master policy can be provided to deliver Difference in Limits
cover above the locally issued policy limits
• Both ABC and their broker have a single point of contact to central
underwriters and claims teams – through appointed client team
contacts within Allianz Global Corporate & Specialty
Outcome
ABC receives rapid and comprehensive cover for this series of trials,
satisfying local regulatory needs per trial whilst having the protection of
a harmonised and consistent global insurance program, centrally
managed and coordinated via one primary point of contact.

Global service in practice.
Allianz Global Corporate
& Specialty’s standard
turnaround time of trial
coverage requests is
5 working days.
Allianz Global Corporate & Specialty has a proven reputation as a
leading provider of International Insurance Programs, with in-depth
experience of delivering tailor-made insurance solutions for clients
with exposure to international multi-location clinical trials.
Worldwide reach
Working through the Allianz global network
and with the client’s brokers, Allianz Global
Corporate & Specialty can offer tailor-made
solutions for multi-national clinical
research programs in more than 50
countries, including important expanding
markets such as Eastern Europe and Asia.
(An updated list of all countries covered by
Allianz for clinical trials is available on
request.) Such international insurance
programs are suitable for clients with
multiple clinical trials in multiple territories
based on multiple protocols.
Speed of response
We recognise that time is of the essence in
clinical trials. This is why our service is designed
to provide clients with a rapid response and
fast turnaround to coverage requests. In 2007,
we provided cover for more than 800 trials
worldwide with an average response time of
5 working days. By adopting an individual
approach to each client’s needs, Allianz
Global Corporate & Specialty can reduce
both the administrative burden that is
associated with such insurance and the time
to issue and deliver local insurance
certificates. For example, on very large
programs, we work with the client and their
broker to classify all clinical trials activities
into categories to which we can apply preagreed
rates. This helps to avoid pricing
delays and enables clients to determine
their annual insurance budget more
accurately.
The Master Policy provides cover for the full length
of each trial (including monitoring periods) that
commences during the policy period.
Consistent cover, centrally managed
Typically a multi-national Clinical Trials
program will consist of a combination of
global Master Policy plus individual local
policies on a per trial/per country basis. This
ensures that the client has the benefit of a
harmonised and consistent insurance
program with internationally recognised
terms and conditions. The Master Policy
provides additional increased limits (DIL)
which are required for larger trials with
many research subjects. Coverage is
provided on a ‘trials attaching’ basis,
covering all trials commencing in the
policy period.

Allianz Global Corporate & Specialty.
Comprehensive risk management solutions worldwide.
Allianz Global Corporate & Specialty was created by harnessing the combined resources of two
of Allianz’s leading international specialists – Allianz Global Risks and Allianz Marine &
Aviation – into one integrated unit. Dedicated to serving the specific needs of corporate and
specialty insurance clients, we offer a comprehensive range of solutions across a wide
spectrum of risks, including:
• Aerospace
• Airlines
• Cargo
• Energy
• Engineering
• Financial Lines (inc D&O)
Contact us
For further information, or for details of your local Allianz Global Corporate & Specialty
Clinical Trials team, please contact:
Dr Andreas Schaer
Allianz Global Corporate & Specialty AG, Munich office
Fritz-Schäffer-Straße 9, 81737 Munich, Germany
Phone + 49.89.38 00 - 13351
Fax + 49.89.38 00 - 813351
andreas.schaer@allianz.com
www.agcs.allianz.com
• General Aviation
• Liability
• Marine Hull
• Property
• Risk Consultancy
• Yachts and Pleasure Craft
Allianz Global Corporate & Specialty Key Facts:
• Serves clients through the Allianz network in more than 150 countries 1
• Provides insurance for more than half the world’s Fortune 500 companies
• Underwrites around h2.9 billion in gross premiums (2008)
• Employs more than 2,000 people worldwide
• Offers the security and capacity of an enlarged balance sheet with an insurer financial
strength rating from Standard & Poor’s of AA (“Very Strong” with stable outlook)
• Joins forces with other Allianz units, such as Mondial Assistance, Allianz Risk Transfer and
Euler Hermes, to develop enterprise risk management solutions
Registered office: Munich, Germany. Commercial Register: Munich HRB 161095
1 This network consists of more than 75 Allianz-owned companies with the balance made up of carefully selected network partners.

Disclaimer & Copyright
Copyright © 2009 Allianz Global Corporate & Specialty.
All rights reserved.
The material contained in this publication is designed to provide general information only. Whilst every effort has been made
to ensure that the information provided is accurate, this information is provided without any representation or warranty of any
kind about its accuracy and Allianz Global Corporate & Specialty cannot be held responsible for any mistakes or omissions.
E
AGCS/0109/HK