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Aon Life Sciences Clinical Trials Risk Map Aon Risk Solutions | Life Sciences Group1+215.255.1857
© Copyright Aon plc 2018. All rights reserved. Published by Aon Global Corporate Marketing and Communications.
The information contained in this map is based on Aon experience as of the publishing date (04/18). The environment (both regulatory and practical) for clinical trials is constantly changing and this map should not be solely relied upon without further consultation from an Aon Life Sciences professional.In addition, ethics committees, regulatory authorities and published guidelines within individual countries can di�er depending upon individual study requirements and the views of individual regulators and ethics committees.
Aon Life Sciences Clinical Trials Risk Map
Aon Risk Solutions Life Sciences Group
6th Edition
Aon Life Sciences GroupOne Liberty Place1650 Market Street, Suite 1000Philadelphia, PA 19103t: 1+215.255.1857e: [email protected]
About Aon Aon plc (NYSE:AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance.
© Aon plc 2018. All rights reserved.The information contained herein and the statements expressed are of a general nature and are not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information and use sources we consider reliable, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation.
www.aon.com
GDM05431
Aon Life Sciences Clinical Trials Risk MapThe globalization of clinical trials continues to be on the rise, leading to a plethora of regulatory and operational challenges for the Life Sciences industry. Aon’s 6th edition Clinical Trials Risk Map highlights clinical trials insurance regulations and complexities for over 80 countries throughout the world leveraging Aon’s global network and clinical trials expertise. Our global network is positioned to help life sciences companies efficiently and effectively secure international clinical trials coverage that complies with the regulatory requirements of individual countries, ultimately minimizing the risk of financial volatility.
Aon Life Sciences GroupThe Aon Life Sciences Group has been assisting life sciences companies with securing international clinical trials insurance for over 30 years. We have the largest equity-owned global network in the world, housing clinical trials specialists who provide our life sciences clients with industry-leading expertise and accountability. Our experts constantly review country-by-country clinical trials regulations in order to provide our clients with industry-leading risk management advisory and brokerage services.
Symbols Illustrating Clinical TrialsInsurance Characteristics
Compulsory Clinical TrialsInsurance Requirements
Key to Symbols
Medical Malpractice is a Standard Policy Extension
Foreign Entity may be Listed as Named on a Local Policy
High Compulsory Limit of Liability = >$5MM
Compulsory AggregateLimit of Liability = <$5MM
Admitted Insurance LawsMay Apply
No CompulsoryClinical Trials Requirements
Compulsory by Law
Compulsory by Law with high ERP or/and LoT
No Data Available Coverage is Available on a No Fault Basis
Standard Clinical Trials Insurance Coverage may not include Trial
Participant Pre-Enrollment Screening
Clinical Trials Insurance Policies allow Direct Reimbursements
to Trial Participants
Required as per local guidelines and/or standard practice
Symbol Definitions:
Compulsory Clinical Trials Insurance Requirements:Government-mandated clinical trial liability insurance, evidenceof which must be provided by sponsors to regulators beforeregulatory authorities will grant approval to commence the trial.
Extended Reporting or Life-of-Trial Requirements:Government-mandated insurance regulations requiring thatclinical trials insurance include extended reporting or “tail” liability for a period of time following the completion of a clinical trial or Life-of-Trial coverage.
Compulsory Limit of Liability:Government-regulated clinical trial insurance with limit of liabilityrequirements (in some countries limit requirements vary bytrial size/number of human subjects).
High Compulsory Limit of Liability:Government-regulated clinical trial insurance with limit of liabilityrequirements in excess of $5 million (in some countries limitrequirements vary by trial size/number of human subjects).
Medical Malpractice is a Standard Policy Extension:Professional liability coverage for trial investigators as part of their participation in the study is a standard coverage under the local clinical trials liability policy.
Coverage is Available on a No Fault Basis:A type of clinical trial liability policy under which insureds are indemnified for losses regardless of fault.
Foreign Entity may be Listed as a Named Insured on a Local Policy:A foreign sponsor can be listed as the named insured under the local clinical trial liability policy without the need of a local legal representative.
Admitted Insurance Requirements May Apply:Local country law requires that insurance be purchased from an admitted or locally licensed insurance company in the country in which the clinical trial is being conducted.
Aon Office:Countries where Aon has a physical presence (in one or multiple cities) and can assist life sciences clients in obtaining local clinical trial insurance and can provide input on local customs and regulations.
The information contained in this map is based on Aon experience as of the publishing date (04/18). The environment (both regulatory and practical) for clinical trials is constantly changing and this map should not be solely relied upon without further consultation from an Aon Life Sciences professional. In addition, ethics committees, regulatory authorities and published guidelines within individual countries can differ depending upon individual study requirements and the views of individual regulators and ethics committees.