In the UK, clinical trials for medical device manufacturers seeking CE marking and pharmaceutical companies wishing to take products to market are vital.
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Conducting clinical trials involves many complex regulatory issues including mitigating risks harming participants, ensuring regulatory compliance, and protecting against financial losses.
It’s crucial to assess insurance needs early, considering how a country’s clinical trial insurance policies might influence where the trials are conducted.
For example, UK law doesn’t mandate insurance, however, the EU Clinical Trials Directive mandates ample indemnity coverage for any harm to participants. Insurance confirms this indemnity, highlighting the need for businesses to work with insurance brokers who are familiar with regulations in different or multi-site locations.
ADF Insurance can arrange two types of clinical trial liability insurance in the UK and overseas including USA and Canada.
Policies may cover the trial duration or be annually renewable, necessitating renewal for trials exceeding one year. Insurers typically request a draft study protocol and patient consent form for quotes, requiring a signed protocol document to initiate coverage.
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