Clinical Trials Insurance

Commercial Insurance Clinical Trial Insurance

The Medicines for Human Use (Clinical Trials) Regulations 2004 (and subsequent amendments) state that a clinical trial may be undertaken only if provision has been made for “insurance or indemnity” to cover the liability of the researchers in relation to the clinical trial. Therefore the relevant approving bodies will insist on Clinical Trial Insurance cover before approval is given, the purpose being to insure the public/products liability as well as no fault compensation.

For peace of mind it is essential that cover is placed with a reputable insurer, clinical trial insurance is only placed with A rated insurers domiciled within the UK.

We cover liability for all phases of clinical trials for drugs and medical devices as well as non-compulsory studies arising from:

  • Negligent Harm: Legal costs, expenses and compensation awarded to the trial’s participants as a result of negligence or a lack of due diligence.
  • Non-Negligent Harm (no-fault): The policy would pay compensation inline with the ABPI guidelines to participants who have suffered harm. There should be a causal link to injury and study participation but the “who, what, when and why” of it is put to one side for the benefit of the injured party.

Underwriting is based on the agreed protocol and informed patient consent form (ICF) which describe the objectives, design, methodology, statistical considerations, and organisation of a clinical trial.