Our expertise in Human Clinical Trials is well-kown and has made us one of the key brokers for the biotech, pharmaceutical and medical device industries. Having worked with human clinical trials insurance for more than 20 years, we know how to obtain the necessary policy documentation from all over the world, and in time. As specialists within the area, we know the legal and insurance-related issues associated with sponsoring and executing a clinical study. 

Or services include:
  • Advice on country specific insurance requirements
  • Assistance in terms of preparing Protocol, Informed Consent, CRO/CMO and Site Agreements or templates
  • Implemening or up-dating SOPs (for insurance purposes)
  • Insurance program set-up
  • Marketing and placement
  • Certificates and policy documents in different languages
  • Claims handling procedures
  • Assistance during and after inspections

For our clients within these industries, we know that time is key. We are available 24/7, used to work within strict deadlines, and have a network of Insurers and brokers around the world, whom we know are able to respond immediately and provide the requested coverage in time. We pride ourselves in never having been the cause of a submission delay.

Our internal Standard Operating Procedure (SOP) is available to clients and CROs. The SOP provides a set of procedures related to the flow of information and documentation needed, it defines responsibilities among the "stakeholders" and help prepare for later inspections and/or discussions with ECs.    

Whether the trial is single or multi-center, whether it is Phase I, II or III, irrespective of number of countries and size of trial population, we provide solid experience and detailed knowledge.