Clinical Trials Insurance
Clinical Trials play an integral role in the process of drug, device, diagnostics and surgical discovery and development. Life Science companies conducting Clinical Trials can face any number of challenges throughout the course of a Clinical Trial, from local regulations to contractual obligations to ethics committee requests. These stringent checks and processes are ultimately designed to guarantee the safety and wellbeing of the participating Research Subjects, whilst ensuring the Research Subjects will be amply compensated in the event that they suffer any injury or damage.
Insurance therefore plays a key role in Clinical Trials as it is commonly used to demonstrate clear evidence to the relevant regulatory body that a Clinical Trial Sponsor has the requisite amount of funding in place to adequately compensate all Research Subjects involved. Whether you are conducting a large multi-center study in multiple countries around the globe, or conducting a small single center study domestically, having the capability to access complex bespoke insurance solutions at a moment’s notice is vital.
At Paragon, we pride ourselves on our ability to provide complex insurance solutions for large multi-center Clinical Trials with the speed and accuracy necessary to ensure our clients avoid delays in the Clinical Trial application process.
Clients we work with:
- Pharmaceutical Companies
- Medical and Surgical Device Companies
- Universities and Colleges
- Contract Research Organizations
- Hospitals and Clinics
- Nutraceutical Companies
- Cosmetic Companies
- Food Companies
- Individual Physicians
In the interests of our clients, we work with market-leading insurers to ensure that information requirements are kept to a minimum at quotation stage, and we can obtain formal terms based upon the following information:
- Clinical Trial Protocol
- Informed Consent Form
- Countries where the Clinical Trial is taking place
- Number of Research Subjects to be enrolled in each of the countries involved.
Whilst each insurer will have their own guidelines to take into consideration when assessing Clinical Trial exposures, a number of general risk factors that may impact upon their final decision are
- Type of Trial
- Medical Devices
- Surgical Procedures
- Non-Interventional Studies
- Phase of Trial for Drugs
- Phases I – IV
- Research Subject Demographic
- Countries the study is taking place in
- Length of Research Subject Participation
- Means of Administration
- Temporary Implants
- Permanent Implants
- Quality of Research Sites
- Stage of Product Development
- Probability and Severity of Side Effects
Regulatory bodies provide guidelines which set out recommended minimum levels of compensation they expect Clinical Trial Sponsors to be able to provide to Research Subjects in the event they suffer any injury or damage. Ethics Committees will review the insurance policy coverage during the application process, to ensure that the insurance coverage satisfies local regulatory requirements. Elements of policy coverage that vary from country to country include, but are not limited to:
- Type of Cover
- No-Fault Compensation
- Legal Liability
- Patient Indemnification
- Limits of Liability
- Extended Reporting Periods
- Legal Costs Inclusive vs Legal Costs in Addition
- Length of Policy Coverage
- Life of Trial
- Annual Renewal
At Paragon, we have a wealth of in-depth country level expertise and the ability to access local markets through key global network partnerships. This enables us to stay up to date with the ever-changing local regulatory requirements and provide expert advice on policy coverage and the latest challenges our clients may face.
Clinical Trial Sponsors and their Research Subjects will often enter into a formal No-Fault Compensation agreement prior to the Clinical Trial commencing. Under the terms of the agreement reached, a Clinical Trial Sponsor is compelled to make an offer of compensation to any Research Subject that suffers injury or damage as a consequence of their participation. The compensation offer is made in accordance with the pre-agreed terms and conditions of the contract and is made without the need to establish or apportion any negligence or liability to any of the parties involved.
A Clinical Trials policy providing legal liability cover would insure against any injury or damage suffered by the Research Subject, as a result of negligence on the part of the Sponsor, or any party conducting the trial on their behalf, such as a principal investigator or contract research organization.
A Clinical Trials policy providing No-Fault Compensation cover would insure against any injury or damage suffered by the Research Subject, where no party was deemed negligent, but where compensation is still paid to the Research Subject under the terms and conditions of a No-Fault Compensation agreement.
- Potential for additional layers of Covid-19 related administration, for any new Clinical Trial applications
- More flexibility around reporting protocol amendments/deviations for current ongoing trials
- Potential delays in product launch dates as a result of delays in Clinical Trial completion
- Site selection issues due to availability and country restrictions
- Restricted access to desired trial patient populations due to a lack of patient willingness to participate and travel restrictions
- Negative impact upon clinical data, with Covid-19 related fatalities requiring patients to be removed from datasets
- The average duration of a Clinical Trial will likely increase
- Research and development and number of Clinical Trials taking place globally will continue to grow.