Grown up with insurance policies in his parents` agency. Classical apprenticeship at Zurich Insurance Company, Central office for Germany in Frankfurt. Underwriter Liability at regional branch. Transition to clients` side, first employed at German`s subsidiary of an American business machine company by the name of AM-International. Ciba-Geigy (Novartis) in Germany appointed him as Managing Director of the inhouse brokerage company. In 2000 he became self-employed and founded Atrialis.
Volker Kraus, PhD developed coverage concepts for pharmaceutical companies and medical device industry by the world’s largest Reinsurer Munich RE.
Studies in chemistry in Erlangen and Munich, focussed on medical toxicology with ensuing promotion. After that he was engaged in research projects of environment by the city of Munich. Transition in 2003 to Munich RE and responsible for risk assessment of chemistry, pharmacology and clinical studies. He worked out expert reports for production of drugs as well as operation of blood banks. He represented Munich RE at regulatory authorities, domestic and foreign, including Food and Drug Administration (FDA) in the U.S.
Burkhardt D. Swik was the former Managing Director of the German Pharma Reinsurance Association (Pharmapool) and Probanden-Cover (Clinical Trials)
Studies of law at the University of Cologne/Germany, attorney in the federal state of Nordrhein-Westfalen. He had leading positions in underwriting and sales by various insurers like Gerling-Konzern and Cologne Re with main focus on international liability for the US-Market. From 2001 until 2019 Managing Director of Pharmapool and Probanden-Cover (Clinical Trials).
Thomas Lacina, PhD our doctor from Switzerland if we need a neutral assessment for special risks of clinical studies
Thomas Lacina studied medicine at University of Bonn / Germany where he got a medical degree. Years later he devoted himself to scientific questions in economics and international politics at the Catholic University of Milan / Italy. He holds the title of Master in Economics and Politics. For more than ten years he has been the team leader of the radiology department as an interventional radiologist at Ars Medica Clinic in Gravesano / Switzerland.
The right clinical trial insurance for every country
Stop time consuming investigations about regulations which authorities and EC demand from you to insure test persons participating in a clinical study.
Instead send us simply a copy of your protocol or synopsis, which comprises number of patients and countries involved. Draft versions will be accepted.
You will shortly receive a reliable offer – black on white. As soon as you have accepted our proposal we will immediately start our work. All necessary documents will be obtained and submitted to you within a few days.
You may continue the start of your study in a very relaxed way.
We will not submit your information to Third parties.
We have never been member of any Social Network and will never be.
Honesty is one of our business principles. Therefore we point to the following exception: No insurance company can draw up an offer without knowledge of your study. Risks must be assessed to calculate a premium. This will possibly also happen with the next step if a special reinsurance is needed. All our partners have agreed to handle information strictly confidential. That is an absolutely normal process in insurance, otherwise we could not manage our business. We assume that you certainly will understand it. Upon request we are prepared to sign a mutual confidential disclosure agreement.
Insight into the world of regulations insuring clinical studies
The World Medical Association established principles with the Declaration of Helsinki in 1964
• Clinical research with humans is strictly forbidden if the risk of studies will be compensated by money • Subjects must be insured against consequences of unexpected events.
Many countries have implemented laws and regulations on human research, some of them include liability for damages. A general European or world-wide accordance does not exist. The differences are most likely visible if specifications have been fixed to limits of indemnity. Next to that are a lot of standard market practises which developed on a voluntary basis. The compensation amount per person is between € 30’000 to € 1’000’000 – only in Europe! Insurance policies which cover studies in several countries cannot be issued due to different laws and languages. Each test person must be able to read and understand the insurance conditions and reference to national law in her/his native language.
ndividual insurance policies per country are therefore indispensable.