Clinical Trial Insurance
Clinical trial insurance is an important section of the liability insurance. This insurance plan offers protection against legal liabilities that arise out of such clinical trials. Clinical trials refer to scientific tests and treatments experimented on people to understand the efficacy of a medicine or medication. A clinical trial insurance covers physical injury, loss of data or property which occurs during the trial.
Need for Clinical Trial Insurance
Organizations carrying out clinical trials face the risk of legal liability to pay research subjects for death, bodily injury, physical or mental illness, disease or impairment caused to research subject as damages by the research.
Clinical Trial Liability Insurance (CTLI) provides cover against legal liability arising out of lack of care, negligence resulting in injury or death of the subject. Insufficient/improper disclosure and conflict of interest may also become subject matter of suit.
- Clinical Trial (Professional Liability) Insurance covers Liability arising out of
- Personal damages
- Liability arising out of Material damages
- Liability arising out of Damages arising from breaches of data protection
- Cost of expert evaluations and reports.
- Other insurance benefits like
- Default interest
- Expert, Legal, Court, Arbitration, and Commission Costs etc
What’s not covered?
- Personal damages and a deterioration of the existing state of health which would have occurred or persisted even without participation in the clinical trial.
- Personal damages that occurred because the trial subject deliberately, or apparently deliberately, contravened the express instructions of the people in charge of carrying out the clinical trial.
- Compensation for ‘punitive damages.
- Damages arising from substances/formulations or preparations listed by the insurer (the insurance company). These substances/formulations or preparations must be listed by name in the “Insurance certificate for the attention of the ethics committees”. Should contraceptive drugs be used as the trial drug or as a compulsory co- medication in the context of a clinical trial, any damages attributable to these contraceptives shall be covered.
- Personal damages to a patient in the control group, insofar as they are attributable to the application of a Drug product that has already been licensed for this indication. However, this does not exclude claims for personal damages attributable to a breach of the obligation to exercise due care by the policyholder or a third party commissioned by it to carry out the clinical trial.
- Personal damages to a patient that do not exceed a certain degree of adverse reactions that are to be expected from the trial drug according to the current state of medical knowledge, insofar and to the extent that comparably serious damages could have occurred if the patient had undergone a standard therapy to treat his illness.
- Personal damages to a patient that do not exceed a certain degree of adverse reactions that are to be expected from the trial drug according to the current state of medical knowledge, in the case of illnesses that ordinarily have a fatal outcome and insofar as no standard therapy exists to treat that illness.
Our team at Emedlife is equipped to advice you on Liability for all phases of clinical trials for drugs and medical devices as well as non-compulsory studies. We have the requisite experience and relevant knowledge to guide you in the right direction.
Talk to us today for all your Clinical Trial insurance needs at an affordable price and for reliable claims management.
For registration of claims and to learn more about our claims process please Contact our dedicated claims team for advice on an incident/claim
D&O Policy protect company director or officer from legal liability arising out of actual or alleged wrongful acts in managing a company.
- The policy covers a wide range of litigation that could arise from customers, vendors, shareholders, employees.
- In addition to defence cost, it provides cover for :
- Investigation Cost
- Entity Protection against Employment Practice Liability claims
- Outside Entity Directorship cover,etc.