Clinical Liability Trial Insurance

Why Do Clinical Trial Sites Require Insurance And/Or An Indemnity

Clinical Trials insurance provides protection for those who sponsor and conduct clinical trials, arising from claims made against them by the trial participants. Cover can be provided on a No Fault Compensation basis to meet Australian Guidelines, including that of the Human Research Ethics Committee.

In additional the above, a legal liability extension can be added, as well as a medical malpractice extension if the trials medical practitioners own defence cover excludes trial work.

Cover can also be provided for:

  • Pre-clinical research
  • Bioequivalence testing
  • Medical devices
  • All phases of drug trial from Phases I to IV

Organisations that conduct clinical trials are often exposed to risks such as condemnation of undamaged stock, property at unspecified locations, spoilage, contamination, crisis response, product recall and regulatory inquiries. Covers are available to develop bespoke policies for these risks.

We have clients based both nationally and worldwide and we can arrange cover either on a per protocol or on an annual declaration basis.

McKenzie Ross can structure a robust, single policy solution that encompasses the multi-facets of exposure, including:

  • Errors and omissions insurance for consequential damages arising from negligent performance or non-performance of any aspect of a trial. Policies generally can cover the costs of repeating a portion or a whole phase of a clinical trial.
  • Medical malpractice coverage for bodily injury claims by subjects arising from medical services or during the course of medical services.
  • Products liability insurance for liability arising out of the handling, distribution, or manufacturing of drugs/medical devices during the pre-clinical and clinical phases, in Phase IV post-marketing surveillance, and thereafter.
  • Clinical trial medical expense coverage, sub-limited to respond to out-of-pocket medical expenses required of trial participants. This coverage can support the insured’s timely response to acute medical needs arising from products administered or services rendered during the trial
  • General liability for premises-related bodily injury/personal injury, property damage and advertising liability claims.
Why do clinical trial sites require insurance and/or an indemnity?

Indemnity and insurance arrangements are taken out to protect the clinical trial site against liabilities that it may incur in the course of its clinical trial activities. In the case of insurance, the insured will typically be the institution, its directors and employees (including researchers).

Although clinical trial participants are neither indemnified or insured parties, insurance and indemnity arrangements ensure that an institution or sponsor is able to compensate participants who are harmed in a trial. For this reason, evidence of appropriate insurance and indemnity arrangements must be provided as part of documentation submitted for ethics review.

If cover is provided by way of an indemnity or managed fund or scheme arrangement, the relevant State or Territory underwrites the risks, however, unlike insurance arrangements, the cover provided under an indemnity or managed fund arrangement may be discretionary leaving your trial exposed to severe losses

Clinical trial researchers who are employees of the relevant private sector entity may be covered under the entity’s clinical trials insurance arrangements. However, many clinicians conducting clinical trials in a private sector entity will not be employees of that entity. Researchers that are not employees are required to have in place professional indemnity or medical indemnity insurance that includes coverage for clinical trials as a condition to participate in the conduct of a clinical trial.

Find out more

As an experienced clinical liability trials insurance broker, our relationships with specialist local clinical trials underwriting agencies ensure we are able to offer a suitable solution for this unique risk.

Contact Luke Lalor on (03) 9691 2222 or luke@mckenzieross.com.au to discuss your clinical trials insurance needs.

Clinical Liability Trial Insurance FAQ’s

Insurance and indemnity arrangements are necessary to protect the clinical trial site against liabilities that it may occur during and as a result of clinical trial activities. This ensures that the institution or sponsor is able to compensate participants who may be harmed during a clinical trial.

An individual or institution typically obtains an insurance policy to protect them from their liabilities and risks. An indemnity is a promise by one party to another that it will cover a loss that arises from an event that happens to the other party.

Clinical liability trial insurance does not pay for clinical trials, but it does protect those who sponsor and conduct clinical trials from claims made against them by the trial participants. An expert insurance broker can clarify what type of coverage you require when conducting clinical trials.

Clinical liability trial insurance can include products liability insurance. It can also include errors and omissions insurance, medical malpractice coverage, products liability insurance, clinical trial medical expense coverage, and general liability.

Indemnity or insurance coverage for clinical trial activities in the public sector are provided by each State and Territory. The Unimutual scheme covers trials conducted by university researchers in the university sector. Sites that conduct clinical trials in the private sector will usually obtain clinical liability trial insurance from a commercial insurance broker.

Clinical trial insurance is a specialised type of insurance that provides coverage for the risks associated with clinical trials. Clinical trials are conducted to test the safety and effectiveness of new drugs, devices, and other medical treatments. The risks associated with clinical trials can include bodily injury or harm to trial participants, damage to property, and financial loss.

Clinical trial insurance typically provides coverage for the following:

  1. Bodily injury or harm to trial participants: Clinical trial insurance can provide coverage for claims arising from bodily injury or harm to trial participants. This can include medical expenses, lost wages, and pain and suffering.
  2. Property damage: You can obtain coverage for damage to property, such as damage to equipment or facilities used in the trial.
  3. Professional liability: The policy can cover claims arising from professional liability, such as allegations of negligence or malpractice by trial personnel.
  4. Product liability: Cover for claims arising from product liability, such as allegations that a drug or device used in the trial caused harm to trial participants.

Policies in this niche vary, so your coverage will be unique and will depend on the policy details and the insurance provider you work with. Familiarise yourself with the terms and conditions of your policy and work with a provider who understands the unique requirements of this insurance niche.

McKenzie Ross is respected in the field and can make sure your cover meets Australian Guidelines. We’ll also ensure your policy is relevant to the specific risks associated with the medical trials you’re involved with. Whether you’re involved with pre-clinical research, medical devices, drug trials or bioequivalence, our team has the necessary insight to assist.

Clinical trials are medical research studies conducted to evaluate the safety and effectiveness of new drugs, medical devices, or treatments. These trials involve human subjects and can pose significant risks to both the participants and the organisations conducting the trials, which is why clinical trial insurance is necessary. It provides coverage for the risks associated with clinical trials.

Clinical trial insurance is intended to provide financial protection for:

  • Trial sponsors
  • Investigators
  • Clinical research organisations (CROs)

The cover safeguards against potential claims or lawsuits arising from the clinical trial and can include compensation for a range of scenarios, ranging from trial participants who experience adverse events or injuries to damages to your assets or property.

Clinical trial insurance policies can be tailored to the specific needs of the trial, and may include general liability insurance, errors and omissions insurance, and professional liability insurance. The coverage may also be customised based on the type of trial, the number of participants, the stage of the research, and other factors.

Having clinical trial insurance is often a requirement for obtaining regulatory approval to conduct a clinical trial. It can also provide peace of mind to the trial sponsors, investigators, and participants by mitigating the financial risks associated with clinical trials.

The McKenzie Ross team’s years of experience and our relationship with local clinical trials underwriting services help us determine what exactly you need, compile a suitable policy for your clinical trial—either per protocol or on an annual basis—and assist with claims when necessary.

It’s difficult to provide a general estimate because the cost of clinical trial insurance can vary depending on a variety of factors:

  1. The type of clinical trial: For example, trials that involve higher-risk interventions or larger numbers of participants may be more expensive to insure.
  2. The length of the trial: Longer trials may have a higher cost due to the extended exposure to risk.
  3. The amount of coverage: Higher coverage limits will generally result in higher premiums.
  4. The insurance provider: Different insurance providers may offer different rates and coverage options.

At McKenzie Ross, we make sure to obtain the best cover at a fair cost to you and throughout your partnership with us, we’ll work closely with you. This ensures you have a clear understanding of the specific coverage your trial has and we’re available if you have any questions along the way.

McKenzie Ross Insurance broking & risk management

Need guidance on the type of commercial insurance product or service that’s best for you? Talk to our broking teams today – Call us on (03) 9691 2222

Key Benefits Of Using McKenzie Ross

High level assurance that risks are transferred where intended.

A greater understanding of the risks retained in your organisation, some of which may require alternative management methods.

A formal process of risk identification that demonstrates good corporate governance to stakeholders.

Linkage between insurance and your organisation’s overall process for risk management.

Enhanced ability for ‘insurable’ risk to be transferred to insurance markets in the best possible light by demonstrating sophistication in identification and analysis.