Clinical Trials What is a clinical trial? A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials, (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Usually they are conducted in phases from small to large groups of people. More and more clinical trials are being conducted overseas, particularly in France, Germany and more recently China. If your retailers are involved in the field of Clinical Trials insurance, they have experienced the frustrations of dealing with the US marketplace when coverage is required for trials to be undertaken outside of the United States. The ability of US carriers to offer broad local terms, issue local policies and issue required documentation on a timely basis is a particular concern. In response to this concern, Internex has engaged the interest of several European underwriters and we have also developed a facility that provides an efficient and effective solution to all clinical trials exposures outside North America. We can turn around quotes quickly to expedite the issuance of required certificates, and to facilitate local policy issuance. Unlike in the US, where insurance is typically secured as a bolt on to a domestic Medical Products Liability policy, we offer clinical trials coverage on a standalone basis. An important feature to highlight here is while any bolt on is obviously subject to annual renewal as part of the overall Medical Products policy, policies issued via Internex are written for the period of the trial in question. Example / Case Study A company had clinical trials coverage in place for a client via a domestic US carrier but this domestic carrier considered an upcoming French clinical trial too risky and declined coverage. Internex was approached for assistance and we were able to secure a stand-alone quotation. The quote included various options based on varying levels of patient participation. Coverage was bound with documentation issued locally to comply with local regulations. How to Request A Clinical Trials Quote Policies are generally specific to one trial, with one limit applying for the duration, a sub-limit per person, and a single premium calculated on the basis of the number of patients to be involved. However, in the event that a client is to undertake multiple trials in one country in the same year, Internex can also offer clients coverage under a single policy. In such instances the policy will provide one limit for all trials, a sub-limit per person, and a minimum and deposit premium, adjustable upon the final number of patients. To secure a quotation for one or a number of trials, we simply require the following underwriting information: A copy of the protocol; A copy of the patient consent form (in English and in local language as appropriate); Confirmation of the number of patients; The address of each study site and the name of the doctor responsible for undertaking the study at each site; and Confirmation of the duration of the trial.