SCIENCE & TECHNOLOGY

Understanding what Clinical Trials Insurance covers and why you need it

Clinical trial insurance is a specialised form of insurance that provides coverage for the unique risks associated with conducting clinical trials.

These trials are conducted to test the safety and efficacy of new drugs, medical devices, and other treatments, and they can be both complex and costly.

Clinical trial insurance helps to protect your business, sponsors, volunteers, investigators, and other parties involved in a trial from financial losses related to the trial. Claims can arise from

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What does Clinical Trials Insurance Cover and Who is it for

As specialist brokers, we work closely with our insurer partners to cover risks associated with running clinical trials.

In most cases, insurance for clinical trials is a regulatory or contractual requirement, where cover is provided on the basis claims can arise from either:

  1. Negligent harm to trial participants: caused as a result of negligence, lack of due diligence/care on the part of the sponsor, investigator or CRO. The policy pays for legal costs & expenses and compensation or “damages” awarded to the participant.
  2. Non-negligent harm (or “no-fault” compensation): harm with no specifically identified cause, but likely to have arisen from the participant taking part in the research. Participants in clinical trials will inevitably sometimes suffer non-negligent harm, with the expectation of being compensated despite there having been no negligence on the part of the sponsor or CRO.

 

Clinical trial insurance typically covers a wide range of risks, including:

  • Third-party liability: Protection against claims made by individuals or organisations that may have been harmed by a trial.
  • Participants’ medical expenses: Coverage for the medical costs of trial participants who may be injured or become ill due to their participation in the trial.
  • Research participants’ death benefit: In the event of a participant death due to a trial, coverage for death benefit payment to the participant’s beneficiaries
  • Property damage: Protection for loss or damage to the trial’s physical assets.
  • Data and intellectual property: Coverage for loss or damage to the trial’s data and other intellectual property.

Who Uses Clinical Trial Insurance?

Clinical trial insurance is commonly used by a wide range of parties involved in clinical trials, including:

  • Sponsors: Pharmaceutical companies, biotech firms, Universities and other organisations that fund and oversee clinical trials.
  • Investigators: Doctors, researchers, and other individuals who conduct and manage the trials.
  • Research sites: Hospitals, clinics, Universities and other facilities where trials are conducted.
  • CROs (Contract Research Organisations): Third-party organisations that provide a wide range of services to support clinical trials.

Why is Clinical Trial Insurance Important?

Clinical trial insurance is essential to managing the risks associated with conducting clinical trials.

Without proper insurance, sponsors, investigators, and other parties involved in a trial could be held financially liable for any losses or damages that may occur. This could result in costly lawsuits, financial losses, and damage to reputations.

In conclusion, clinical trial insurance is a vital tool for managing the risks associated with clinical trials and protecting the financial interests of all parties involved. It covers a wide range of potential risks, from third-party liability to participants’ medical expenses and more, providing peace of mind for everyone involved in the trial.

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