Clinical Trials Insurance. Global solutions for clinical trials liability

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1 Clinical Trials Insurance Global solutions for clinical trials liability

2 Specialist cover for clinical research. 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. Global Partnership for Global Trials 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

3 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.

4 Global service in practice. 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 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 s standard turnaround time of trial coverage requests is 5 working days. 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.

5 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) 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 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, Munich, Germany Phone Fax Registered office: Munich, Germany. Commercial Register: Munich HRB This network consists of more than 75 Allianz-owned companies with the balance made up of carefully selected network partners.

6 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

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