Essential Insurance Considerations Prior to Commencing a Clinical Trial

22 October 2026

Clinical trials are a critical milestone in the development of new medicines, medical devices and therapies. They represent years of research, significant financial investment and the opportunity to bring innovative treatments to market. However, they also introduce a range of risks that should be carefully considered before the first participant is enrolled.

From meeting regulatory and contractual requirements to managing operational, cyber and governance risks, taking a structured approach to risk management can help organisations prepare for the challenges that may arise throughout the course of a study. Reviewing insurance arrangements as part of this process can also support wider planning and decision-making.

Why insurance matters in clinical trials

Clinical trials involve multiple stakeholders, including sponsors, investigators, research institutions, contract research organisations (CROs), regulators and participants. While extensive protocols and risk management procedures are designed to help support the safe delivery of studies, unforeseen events can still occur.

Insurance should be considered as part of a broader risk management strategy when planning and conducting clinical research. Reviewing insurance arrangements alongside governance, contractual and operational considerations can help organisations assess whether they're appropriately prepared for the specific risks associated with their study.

For many trials, evidence of insurance may also be required before trial approval, site activation or contractual agreements can be finalised.

Understanding the risks involved in clinical development

Every clinical trial is different, but there are several common risk areas that sponsors should evaluate before a study begins.

Participant injury allegations

The welfare of trial participants remains one of the highest priorities throughout any study. Despite rigorous testing, monitoring and oversight, participants may experience adverse reactions or unforeseen complications.

For this reason, sponsors often review their clinical trials insurance arrangements before a study begins. Depending on the policy terms, conditions and exclusions, such cover may be relevant where allegations of injury, illness or other loss arise in connection with participation in a trial.

Protocol deviations and operational disruption

Clinical studies often operate within strict timelines and budgets. Delays caused by recruitment challenges, supply chain interruptions, damaged research materials or operational issues can have a significant impact on development programmes.

While insurance forms only one part of a broader risk management strategy, organisations may wish to consider whether their insurance arrangements remain appropriate for the operational risks associated with a study.

International trial exposures

Many organisations conduct trials across multiple territories, introducing additional legal, contractual and regulatory complexities.

Insurance requirements can vary significantly between countries, with some jurisdictions requiring locally admitted policies or specific compensation provisions for participants. Organisations planning multinational studies should review their insurance arrangements alongside local regulatory and contractual requirements before recruitment begins.

Data protection and cyber considerations

Clinical trials generate significant volumes of sensitive information, including participant data, research findings and commercially valuable intellectual property.

Cyber incidents, ransomware attacks and data breaches can disrupt studies, create regulatory concerns and potentially affect stakeholder confidence. As digital technologies, cloud-based platforms and electronic data capture systems become more widely used across clinical research, organisations may wish to review cyber risk management as part of their overall study planning process.

This may include considering cyber liability insurance alongside wider cyber security measures, contractual obligations and regulatory requirements.

Intellectual property considerations

Clinical trials generate valuable data that may support future patent applications, regulatory submissions, licensing agreements and commercialisation strategies.

As organisations work with research institutions, investigators, contract research organisations (CROs) and other third parties, it's important to establish clear agreements regarding data ownership, confidentiality and intellectual property rights. Uncertainty around these arrangements can lead to disputes, delays or challenges as a study progresses.

Sponsors may wish to review how intellectual property risks are managed as part of their wider governance, contractual and risk management framework before a trial begins.

Contractual responsibilities

Sponsors often work with CROs, research institutions, laboratories and manufacturing partners. These arrangements frequently include insurance obligations that may specify minimum cover limits, policy requirements or indemnity provisions.

Understanding these requirements early can help organisations identify potential gaps and support smoother study planning and implementation.

Key insurance covers to consider

The insurance requirements for a clinical trial will depend on factors such as study design, participant numbers, geography and organisational structure. However, several types of cover are commonly reviewed before a trial begins.

Clinical trials insurance

Clinical trials insurance is often an important consideration for organisations conducting human studies.

Policy requirements may vary depending on the nature of the trial, participating institutions and the jurisdictions involved. Sponsors should review cover limits, territorial scope and policy wording to ensure they're appropriate for the study's specific circumstances.

Product liability insurance

As clinical development progresses, organisations may wish to consider whether product liability insurance is appropriate, particularly where investigational products are being manufactured, supplied or distributed.

The suitability of any cover will depend on the organisation's activities, risk profile and the terms of the policy being considered.

Directors' and officers' liability insurance

Clinical development programmes often involve significant investment and strategic decision-making. Directors and senior leaders may face scrutiny from investors, shareholders or other stakeholders regarding organisational decisions and governance.

As part of a broader risk management review, organisations may wish to consider whether directors' and officers' liability insurance remains appropriate for their needs.

Professional indemnity insurance

Organisations providing research services, consultancy or specialist scientific advice may wish to consider whether professional indemnity insurance is appropriate for their activities.

When reviewing insurance arrangements, it's important to consider the nature of services being delivered, contractual requirements and the specific terms, conditions and exclusions of any policy.

Questions to ask before your study begins

Before initiating a trial, organisations should assess whether their insurance arrangements accurately reflect the nature and scale of the study.

Key questions may include:

Do insurance arrangements meet the requirements of participating sites and countries?
Are cover limits, terms and conditions appropriate for the activities being undertaken?
Will the trial involve international participants or overseas locations?
Are contracts with CROs, research institutions and other partners aligned with insurance arrangements?
Have cyber, data protection and intellectual property considerations been reviewed?
Have wider organisational risks and governance responsibilities been considered?

Addressing these considerations early can help reduce delays and support smoother study implementation.

Insurance requirements evolve as clinical trials progress

Insurance needs rarely remain static throughout the development lifecycle.

Early-stage studies may focus primarily on participant-related and contractual considerations. However, as organisations move through later-phase trials, secure additional funding or prepare for commercialisation, their risk profile may evolve considerably.

New considerations may include expanded international operations, manufacturing activities, product distribution, intellectual property exposures and increasingly complex contractual arrangements. Regular reviews can help ensure insurance arrangements remain aligned with the organisation's activities and objectives.

Preparing for a successful trial

Clinical trials represent a significant investment in both innovation and future growth. While every study carries uncertainty, understanding potential risks and reviewing insurance requirements before recruitment begins can help organisations take a more informed approach to planning and risk management.

By considering participant, operational, cyber, intellectual property and contractual risks at an early stage, life sciences organisations can focus on advancing research and progressing towards their clinical development objectives.

Let us help you review your clinical trial risks

Every clinical trial is different, with insurance requirements varying according to the study design, locations involved and stage of development.

Speak to Gallagher's Life Sciences team to discuss the considerations relevant to your organisation and explore how insurance can form part of your wider clinical trial risk management strategy.

Disclaimer

These are brief product descriptions only. Please refer to the policy documentation paying particular attention to the terms and conditions, exclusions, warranties, subjectivities, excesses and any endorsements.

The sole purpose of this article is to provide guidance on the issues covered. This article is not intended to give legal advice, and, accordingly, it should not be relied upon. It should not be regarded as a comprehensive statement of the law and/or market practice in this area. We make no claims as to the completeness or accuracy of the information contained herein or in the links which were live at the date of publication. You should not act upon (or should refrain from acting upon) information in this publication without first seeking specific legal and/or specialist advice. Arthur J. Gallagher Insurance Brokers Limited accepts no liability for any inaccuracy, omission or mistake in this publication, nor will we be responsible for any loss which may be suffered as a result of any person relying on the information contained herein.