Life sciences

Clinical Trials Liability Insurance

Clinical trials liability insurance supports businesses where research activity, protocol decisions, investigational products, informed consent, adverse events or participant injury could create specialist liability exposure.

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Who It Is For

  • Life-science companies sponsoring or supporting clinical trials
  • Clinical research and trial-management organisations
  • Biotech, pharma, medtech and diagnostics businesses moving into human-use studies

Cover To Review

  • Clinical trials liability and participant injury exposure
  • Products liability for investigational products
  • Professional indemnity for protocol, monitoring or research services
  • Cyber, data, equipment and business interruption where relevant

Underwriting Detail

  • Trial phase, territory and participant numbers
  • Protocol, consent, ethics and governance arrangements
  • Product type, intervention level and adverse-event profile
  • Sponsor, CRO, site and investigator responsibilities

Clinical Trials Liability Insurance FAQs

Who needs clinical trials liability insurance?Sponsors, clinical-stage product businesses, CROs and some research organisations may need specialist cover depending on their role and contract responsibilities.

Is trial liability the same as product liability?No. Product liability focuses on the product, while trial liability can also involve protocol, participant injury, consent, monitoring and research governance issues.

What information is needed for quotes?Insurers usually need protocol details, phase, territory, participant numbers, product type, contracts, ethics approval and claims history.