Clinical Trials Indemnity Insurance
Clinical Trials insurance is a highly sensitive and delicate area of insurance, given that they often require coverage in multiple jurisdictions, often covering more than one trial, ranging from one day to 10 years.
Although Clinical Trials is heavily regulated sector throughout the US, Canada and Europe, the review board or ethics committee will often require verification of insurance, often from an ‘A’ rated and reputable insurer before allowing a trial(s) to commence.
We work with our clients to help them understand the risks involved to human life and reputational damages when things do not go to plan or there is an adverse impact which has a considerable knock-on effect.
As a specialist healthcare intermediary, we work with you to ensure that there are no 'gaps' in cover and to ensure that business has sufficient cover in place to cover management/directors through to technicians and support staff.
Examples of Clinical Trial Claims
- Participants rejecting the compensation guidelines, thus seeking to pursue a claim for increased damages.
- Trial participants being harmed, often with long-term illness / psychological effects.
- Participants (or their dependants) demanding compensation The reputation damage and business interruption when dealing with claims can be disastrous, which is why is it essential that you partner with a specialist broker with dedicated resources to respond when things don’t go to plan.
How can we protect you with Clinical Trial Insurance?
We have extensive specialist healthcare experience in arranging Clinical Trials insurance globally with direct access to Lloyd’s of London for the competitive placement of your insurance requirements, backed with specialist support and claims handling. Our coverage limits vary from £1m to £100m, subject to your specific requirements and exposures.
What do we need to cover you?
Information we will work with you to obtain, in order for us to present your requirements to our specialist insurers:
- The indemnity limit required for liability insurance – often set by the ethics committee (also known as “institutional review boards” in the USA).
- Location(s) of the trial
- The Process Document, which acts as the trial protocols, and includes details such as:
- Trial participants – how many, ages, genders etc. Trials involving vulnerable groups such as children and women of child-bearing age will come under particular scrutiny.
- Informed consent documents – description of the purpose of the trial, its potential risks and benefits, procedures and duration etc.
- Details of the Investigator or CRO who will conduct the trial
What protection does Clinical Trials insurance provide
Clinical Trial Insurance provides protection in two ways:
- Non-negligent harm / “no-fault” compensation: harm to participants of clinical trials with no identified cause, but likely to have arisen from their involvement in the research. The policy pays compensation in line with guidelines set out by competent authorities, such as the Association of British Pharmaceutical Industries.
- Negligent harm to trial participants: caused as a result of lack of due diligence/care or negligence by the sponsor, investigator or CRO. The policy pays for legal costs & expenses and compensation or “damages” awarded to the participant.
How can I reduce my clinical trials risk exposure?
We recommend our clients to follow our guidelines for risk management when conducting business on a day to day basis. As such, as recommend:
- A clear and informed consent process.
- Trial monitoring
- Reviewing any financial interests the clinical investigators to avoid scenarios of Conflict of Interests.
- The qualifications of the investigators and the make-up of ethics committees or institutional review boards
- The ethics of participant recruitment techniques