EXCESS OF LOSS LIABILITY FOR CLINICAL TRIAL INSURANCE

A loss incurred in the course of a multinational trial conducted in several different countries may not be sufficiently covered by the amount insured mandated by local regulations, resulting in additional costs for the sponsor.

In certain countries local insurance policies contain a list of exclusions. It is therefore possible that in a multinational trial local exclusions applying to one country are included in the coverage in another country.

Extended liability periods vary from country to country, which means that the trial participant faces different deadlines for reporting an incurred loss to the insurer.

A special coverage concept – an excess of loss liability policy – provides protection against diverging coverage levels and conditions (DIC-DIL policy).

TRAVEL ACCIDENT INSURANCE; RADIATION LIABILITY COVERAGE; SPECIAL CASES

Although not mandatory in Germany, ethics committees increasingly recommend obtaining travel accident coverage in addition to clinical trial insurance. It covers direct travel from the test person’s home or place of work to the place of the clinical trial and back.

Nuclear accident liability coverage in addition to clinical trial insurance is mandatory for clinical trials subject to the extensive approval process of the German Federal Office for Radiation Protection.

For trials not subject to the German Medicines Act and Medical Product Law it is not mandatory to obtain clinical trial insurance in Germany. These include trials of dietary supplements, cosmetic products as well as comparative trials of already approved processes.

In this case optional clinical trial insurance with a lower coverage level and premiums may be obtained to ensure adequate coverage of the test persons in case of damage.

For these and other special cases we offer customized solutions. Always tailored to your clinical trial.