Life SciencesLiability
Contact
SpecialtyAggressive — Push Back

Clinical Trial Liability

What this clause says

Clinical Trial Liability insurance with limits of not less than $5,000,000 per occurrence and in the aggregate, covering bodily injury to human research subjects arising out of Sponsor's clinical trials.

What this means in plain English

Specific coverage for harm to human subjects participating in a clinical study.

What it means for a CDMO program

For a CDMO making investigational product, this coverage is almost always carried by the SPONSOR, not you. Read the MSA carefully — if the sponsor is asking the manufacturer to carry CTL, that is non-standard and worth pushing back on. CROs running the trial may carry it depending on contract structure.

How this evaluates

The Decoder applies these rules in order; the first match wins.

  • clinical trial › required is not set → Compliant: CTL not applicable to your role.
  • clinical trial › limit is at least $5M → Compliant: CTL in place at required limit.
  • clinical trial › required is set → Gap: CTL required but not in place — verify whether sponsor or manufacturer should carry.

See this in your MSA

Pre-loaded with this clause selected.

Run the Decoder

Related clauses

Questions about specialty

Clinical Trial Liability — common questions

Why would a sponsor push clinical trial liability onto a CRO?

+

Cost shifting, mostly. Sponsors normally carry it themselves; pushing it onto the CRO sometimes happens when the CRO is the named investigator or when the sponsor is a startup with limited insurance capacity.

Can a CRO get clinical trial liability?

+

Yes — the dedicated life-sciences markets and several London-market layers will write it for CROs. Premium is meaningful and depends on subject count, indication, and protocol risk.

What is the boundary with E&O?

+

Clinical trial liability covers subject-injury claims arising from trial conduct. E&O covers errors in study design, data analysis, regulatory work. Coordination language on the COI determines who pays first when both could respond.