The ideal protection for university hospitals and research institutions
Why is special insurance for clinical trials at university hospitals so important?
Ansgar Kentrup: Insurance for clinical trials is essential because it covers the risks associated with research into new drugs or treatment methods. Clinical trials are as much about the well-being of the patients as they are about protecting the clinics and researchers. Participants could suffer unexpected side effects and clinics need to protect themselves against potential liability claims. Without special insurance, the financial consequences of a lawsuit or damage could be enormous.
What makes insurance for clinical trials special compared to other types of insurance?
Clinical trials involve many risks that go beyond the cover provided by normal liability insurance. This is due to the uncertainty about the effect of new drugs or therapies. These studies often operate in the realm of the unknown, which means that the probability of unexpected incidents is high. A special insurance policy therefore not only covers possible damage to the health of the test subjects - that is, the participating patients - but also protects against regulatory violations or complications that may arise during the conduct of the study.
How can an insurance broker support university hospitals and research organisations?
An insurance broker plays a crucial role here by assessing the specific risks of a clinical trial and offering customised insurance solutions. Every trial is different, so it requires a deep understanding of the nature of the research, the participants and the potential legal challenges. As a broker, we analyse the needs of the clinic and work closely with those responsible to find a suitable insurance policy. We also help with compliance with legal regulations, which are particularly strict for clinical trials in Germany.
Are there also risk management services that a broker can offer in connection with clinical trials?
Absolutely. In addition to traditional insurance advice, we also offer comprehensive risk management services. This includes identifying potential risks, recommending preventative measures and training staff on safety precautions. We can also help to optimise internal processes to minimise the risk of damage or legal problems. This holistic approach ensures that clinics are not only well protected in the event of a claim, but also actively manage risks in advance. At Ecclesia, we also offer our customers the opportunity to map all of this using a digital tool. Together with university hospitals, we have developed this function, which allows our customers to manage all studies at the respective hospital in one place. They have a complete overview, access to all relevant documents and can track the respective status of the studies.
How do legal requirements influence the design of insurance policies for clinical trials?
In Germany, clinical trials are regulated by very strict legal requirements, especially when it comes to the protection of test subjects. According to the German Medicines Act, for example, clinical trials must always have liability insurance to cover participants against possible damage. These requirements make it essential that university hospitals not only take out a standard insurance policy, but also a policy that specifically fulfils all regulatory requirements. An insurance broker can ensure that the insurance policy fulfils the legal requirements and at the same time offers comprehensive protection.
What is the added value of working with the Ecclesia Group in this area?
The greatest added value lies in the personalised support. We bring expertise and experience that enables the clinic to precisely understand and insure against the risks of a clinical trial. In addition, we take the burden off our customers by coordinating all aspects of the insurance, from choosing the right policy to claims handling. This saves time and provides peace of mind, allowing the clinic to focus on what really matters - medical progress and the well-being of patients.
Why can't the clinic in question do this itself? What is the advantage of the insurance broker here?
The clinic or research institution could theoretically try to manage the risks itself and take out insurance policies. However, they often lack the specialised knowledge to correctly assess the complex and diverse risks of clinical trials and find a suitable insurance solution. This is where we come in as insurance brokers: We not only bring in-depth expertise about the market, but also the ability to develop customised solutions that take into account both the regulatory requirements and the specific needs of the clinic. We act as an independent intermediary and can negotiate the best conditions between different providers, which takes the pressure off the clinic or research organisation and leads to better results.