Our Insurance Comparison Tool allows you to pick the policy that's right for you by comparing every plan offered by Canada's leading insurance providers. Need some clarification? Our Frequently Asked Questions can help you learn more about Clinical Trials Liability.
Compare Clinical Trials Liability Insurance Policies
|Product name||Max Coverage||Min Premium||Exclusions|
|Public and Products Liability by Newline Australia Insurance Pty Ltd||Max Coverage AUD30M||Min Premium N/A||
|Clinical Trials by Newline Australia Insurance Pty Ltd||Max Coverage AUD20M||Min Premium N/A||
|Tailored Life Sciences and Clinical Trials Solutions by Newline Australia Insurance Pty Ltd||Max Coverage AUD30M||Min Premium N/A||
|Pharmaceutical, Biotech and Lifescience Liability by ASR Underwriting Agencies Pty Ltd||Max Coverage AUD20M||Min Premium N/A||
|Clinical Trials by Edge Underwriting Pty Ltd||Max Coverage N/A||Min Premium N/A||
|Single Project by MECON Insurance Group Pty Ltd||Max Coverage AUD300M||Min Premium N/A||
|Annual Project by MECON Insurance Group Pty Ltd||Max Coverage AUD300M||Min Premium N/A||
|No Fault Compensation for Human Clinical Trials (Claims Made) by Pen Underwriting Pty Ltd||Max Coverage N/A||Min Premium N/A||
Frequently Asked Questions(click to expand)
What Is Clinical Trials Liability Insurance?
Clinical Trials Liability insurance provides coverage for researchers and developers in the event of harm caused to a participant of a clinical trial and any compensation required as a result.
As clinical trials for medications and other products are conducted on human volunteers, rigorous controls and procedures must be in place to ensure the well-being of the participants. A Clinical Trials Liability insurance policy will ensure that any group or organization performing a trial is sufficiently covered in case anything goes wrong.
Who Needs Clinical Trials Liability Insurance?
A clinical trial may be conducted by a developer or sponsor. However they may also engage a Clinical investigator or CRO (Contract Research Organization) to conduct the research and trial on their behalf. While product developers can often simulate organisms and test products on cloned or dead tissue, live human volunteers are normally required in the latter stages of the research and development of a clinical trial. Despite the trials being conducted in a strictly controlled environment, there can be certain results or side-effects that can complicate or disrupt the trial due to any adverse reaction.
Any loss or damage caused to the developers of the trial or the pharmaceuticals used may need to be covered separately – under a Commercial General Liability insurance policy.
What Are The Different Type Of Clinical Trial?
- Phase I trial: When a new drug or treatment is trialled for the first time to identify safe dosage range and identify side effects
- Phase II trial: trialling of drug or treatment to a larger group of people to test effectiveness and safety
- Phase III trial: trialling of drug or treatment to large groups of people to test effectiveness, side effects and to compare usage with other medications
- Phase IV trial: post-marketing studies to detail drug or treatment’s benefits and risks
What Are The Main Risk Areas Normally Associated With Clinical Trials?
As medical researchers, scientists are responsible for the health and safety of all volunteers participating in a clinical trial, regardless of whether they are genuinely trialling a pharmaceutical or placebo.
Types of risk associated with clinical trials include:
- physical pain
- bleeding and bruising
- adverse reactions to other medications
- latter stage symptoms
Some symptoms and side effects may be predicted but some may be unexpected. To avoid a claim of negligence or lack of due diligence and care, the investigator or developer of the clinical trial must detail every possible scenario side effect or symptom, no matter how severe, that they think may occur in order to brief all participants accurately and responsibly.
What Does Clinical Trials Liability Insurance Cover?
Clinical Trials insurance usually provides coverage for two main areas:
negligent harm to trial participants/volunteers: coverage for legal costs, expenses and damages awarded to the participant in the case of an act of negligence from the sponsor, investigator or CRO of the trial
non-negligent harm (no-fault compensation): coverage for compensation awarded to the participant if they suffer non-negligent harm (side-effects and symptoms) during the course of the clinical study
What Is Not Included In Clinical Trials Liability Insurance?
If an error or omission resulted in one of these invalid participants accidentally being included then that may affect a claim.
Participants ineligible for study may include:
- those outside of a pre-determined age range
- participants on particular types of medication
- participants with certain pre-existing conditions
- pregnant participants
Intentional acts or harm caused deliberately to a participant during a clinical trial will also most likely be excluded. The same may apply if there are issue regarding the qualifications of the investigators and the make-up of ethics committees or institutional review boards.
How Much Does Clinical Trials Liability Insurance Cost?
- the size of the pharmaceutical company
- the nature of the study
- any potential rehabilitation or healthcare costs required for participants
- estimated costs for brand reparation in a worst-case scenario involving severe harm caused to the participants