Clinical Trial Insurance 365

The Challenge – Managing International Clinical Trials

Clinical trials are critical to advancing therapies and improving patient outcomes, but the environment for sponsors has never been more complex. Rapid regulatory change, evolving local requirements and increasing operational demands all raise the risk profile of global trials.

Sponsors must:

• Address country specific insurance and regulatory requirements
• Ensure contractual obligations to investigators, sites and partners are met
• Manage costs and timelines while protecting against trial related liabilities
• Maintain robust documentation to support submissions and audits

Without a coordinated approach, clinical trial insurance can become a barrier to timely study start up and ongoing compliance.

Introducing: Clinical Trial Insurance 365

Clinical Trial Insurance 365 is Aon’s integrated solution to help Life Sciences organizations manage clinical trial liability programs worldwide. Built around our proprietary global online platform and supported by a dedicated Clinical Trial Liability team, the solution is designed to:

• Support the business through timely regulatory insurance submissions
• Help ensure long term regulatory and contractual compliance
• Protect the organization from liability arising from clinical research
• Drive operational efficiency through best in class service and technology
• Manage costs while maintaining appropriate levels of protection

What Clinical Trial Insurance 365 Delivers

1. Specialized clinical trial liability expertise

Aon’s Life Sciences and Clinical Trial Liability specialists focus exclusively on the risks facing sponsors and their partners. Our team manages all aspects of trial insurance programs, including:

• Program design, placement and brokerage
• Day to day program administration
• Claims coordination and advocacy
• Contract reviews for insurance and indemnity provisions

2. Proprietary global online platform

At the core of Clinical Trial Insurance 365 is Aon’s proprietary online platform for clinical trials, built to simplify and centralize insurance management across studies and geographies.

Key capabilities include:

• Information sharing
  Institutional knowledge for clients, study teams and CROs on all clinical trial insurance placements and documentation.
• Simplified quote/bind
  A structured, automated process to help you obtain accurate quotes and bind coverage faster, supporting timely study start up.
• Streamlined documentation
  Tools for requesting country specific documents, managing revisions and maintaining complete, up to date records.
• Smart repository
  Automatic storage of documentation and correspondence, reducing administrative burden and enabling quick retrieval for audits and submissions.
• Dashboards and visibility
  Configurable dashboards that provide visibility into program metrics and performance across countries, trials and phases.

3. Technology and innovation, powered by strategic partnerships

Clinical Trial Insurance 365 incorporates advanced risk management technology, including a partnership with Ventiv Technology, to enhance data, analytics and decision making for sponsors. This technology forward approach has been recognized with a European Risk Management Award for innovation on a similar client solution.

Benefits for Clinical Trial Sponsors

By using Clinical Trial Insurance 365, sponsors can:

• Accelerate trial startup
  Reduce delays linked to insurance certificates, documentation gaps and country specific requirements.
• Enhance regulatory and contractual compliance
  Support regulatory submissions and maintain a clear audit trail across all trials and geographies.
• Improve operational efficiency
  Free up internal resources by centralizing information, standardizing processes and automating documentation management.
• Gain global visibility and control
  Use dashboards and reporting to monitor placements, renewals and program performance across your portfolio of trials.
• Manage cost and risk more effectively
  Align coverage levels, limits and retentions with your risk appetite, aided by Aon’s life sciences market insight and data.

Who Clinical Trial Insurance 365 is For

Clinical Trial Insurance 365 is designed for:

• Biotech and pharmaceutical sponsors conducting multi country or global clinical trials
• Medical device and diagnostics companies running pre and post market studies
• Contract research organizations (CROs) supporting sponsors in high complexity programs
• Life sciences organizations seeking to scale trial activity with greater control and transparency

This document is not intended to address any specific situation or to provide legal, regulatory, financial, or other advice. While care has been taken in the production of this document, Aon does not warrant, represent or guarantee the accuracy, adequacy, completeness or fitness for any purpose of the document or any part of it and can accept no liability for any loss incurred in any way by any person who may rely on it. Any recipient shall be responsible for the use to which it puts this document. This document has been compiled using information available to us up to its date of publication and is subject to any qualifications made in the document.