Patients take part in medical research projects in which, for example, pharmaceutical
products and medical devices are studied prior to market approval. Because participation
in clinical trials can be associated with increased health risks, the law in many
countries requires compulsory clinical trial insurance. HDI Global SE offers appropriate
There can be no medical progress without research. Before pharmaceutical products and medical devices are approved, the function, effect and safety must be tested on humans. This happens by means of clinical trials. Clinical trials are also an effective means of gaining scientifically substantiated knowledge about new examination and treatment methods. This important mode of inquiry does not come without a degree of risk to the participating patients. HDI Global can supply the necessary insurance solutions to meet the various requirements and legal demands prescribed for this marketplace.
Clinical trial insurance is available on a project to project basis (project coverage), or through an annual contract.
Who is this insurance intended for?
In most countries insurance is necessary in order to obtain an official permit from the authorities to carry out a clinical trial. Sponsors of clinical trials for pharmaceutical products or medical devices must prove that they have insurance coverage in compliance with local legal requirements.
Clinical trials worldwide
Special insurance is required for the performing of clinical trials in many countries. Country-specific requirements differ greatly. HDI Global SE has many years of know-how in the field of clinical trials and provides the necessary insurance cover for companies worldwide, for national as well as for multinational studies. This is arranged through our own units in many countries as well as through an international network.
Insurance for clinical trials performed in Germany
Insurance is compulsory for two types of clinical trials in Germany:
clinical trials of pharmaceutical products in accordance with the German Pharmaceutical Products Act (AMG)
clinical trials of medical devices in accordance with the German Medical Devices Act (MPG)
Many sponsors also take out appropriate insurance to protect patients participating in other types of clinical trials for which there is no legal requirement for insurance, e.g. new examination and treatment methods (non-compulsory insurance for clinical trials).
Services at a glance
Clinical trial insurance provides compensation in the event of physical damage to the patient through the clinical trial as well as in the events of health impairment and death. As "insured persons", the participating patients have their own direct claim against the insurer, independently of whether someone is liable for the damage incurred.
In the event of bodily injury or damage to the health of the insured person:
Regular payments in the event of restriction to or loss of ability to work
Other increased expenses
In the event of the death of the insured person:
Maintenance for surviving dependants for the assumed duration of the insured person’s life
In certain cases, radiation liability insurance is compulsory for clinical trials in Germany involving radioactive materials. It can be required in addition to clinical trial insurance. HDI provides the necessary coverage to its clients.
Proven specialist competence with many years of experience
Proven expertise and many years of experience in the industry substantiate HDI Global SE as a market leader in this area.
Global and national insurance solutions
An international network enables the appropriate insurance cover beyond borders.
High service quality
Low processing effort, quick issue of local insurance certificates required for the authorities and uncomplicated claims processing.
Expert´s tip on product liability
Access to a more comfortable scope of cover with Medical Monitoring.
HDI has created legal security for implant manufacturers by means of a new clause: In the event of potential product defects, monitoring costs for medical check-ups as the result of a suspected, but not proven, defect of medical products (Medical Monitoring) are covered. Since the costs are regulated as part of the personal injury cover, policyholders will have a comfortable scope of cover.