Clinical Trial Insurance for MedTech, IVD, and Digital Health
Get quote-ready in 2 minutes. Clinical trial liability insurance (also called clinical trials liability coverage) made simple: use the readiness checker, build a submission pack PDF, and route to 3 specialist markets with one click.
1. Trial Insurance Readiness Checker
Answer the essentials. We will highlight likely limits, COI wording needs, and missing items.
Readiness output
Fill the fields above to see your likely limits, COI notes, and missing items.
Common missing items
Submission checklist (copy/paste)
2. Auto-Generated Submission Pack (PDF)
Use the preview, download a PDF, or send directly to Cruxi for routing.
Pack preview
Actions
Send to 3 specialist markets
We will route your pack to specialists and follow up within 24-48 hours.
3. Requirements by Geography
Select a region to see common COI wording and documentation needs.
Clinical trial insurance keywords (what buyers actually search)
These terms show up most often in insurer and broker language. Use them in internal approvals, ethics submissions, and quote requests.
Core coverage terms
- Clinical trials liability insurance (also called clinical trial liability coverage) typically covers injury claims from research participants.
- Clinical trial insurance / clinical trials insurance is common shorthand for the same coverage in insurer materials.
- Clinical trial indemnity insurance is often used to describe the sponsor/investigator indemnity obligations around trial-related injury.
- No-fault compensation refers to coverage that can respond even without negligence, which some jurisdictions and policies address explicitly.
- Medical device clinical trial insurance (including IVD and SaMD) is a common variant term used in life‑sciences insurance materials.
Paperwork & territory searches
- Certificate of insurance (COI) is commonly requested by sites/ethics committees as evidence of insurance or indemnity.
- Admitted / local policies are often needed for multi-country trials to meet local compliance and language requirements.
- Clinical trial insurance UK / EU / US signals jurisdiction-specific expectations (e.g., evidence of insurance for non‑NHS sponsors in the UK).
Clinical trial liability insurance requirements (UK/EU/Global)
These are evidence-based notes you can use in internal approvals and IRB/ethics submissions.
UK & NHS expectations
- UK regulations require insurance/indemnity to cover sponsor and investigator liabilities for trial-related injury.
- When the sponsor is not an NHS body, evidence of insurance or indemnity is typically required for approvals.
- NHS indemnity covers negligent harm, but not non-negligent harm; non‑NHS sponsors should arrange separate cover.
Multi-country & admitted coverage
- Multi-country trials may require local admitted policies and local‑language documentation in each territory.
- Specialist insurers provide admitted coverage and local compliance support for each country.
- Some jurisdictions require insurance by law, while others (including the US) may not mandate it.
Who needs clinical trial insurance?
Clinical trial insurance (or clinical trial liability insurance) is typically required for sponsors of clinical trials — including pharmaceutical, biotech, and MedTech, IVD, and digital health companies — as well as CROs and sometimes sites or investigators. In the UK and EU, ethics committees and regulators often require evidence of insurance or indemnity before study start; the same is common for US sites and IRBs. If you are running a device trial (e.g. first-in-human, feasibility, or pivotal), you will usually need a bindable quote or policy in place before recruitment.
How much does clinical trial insurance cost?
Clinical trial insurance cost depends on study stage (e.g. first-in-human vs pivotal vs post-market), geography (UK, EU, US, multi-country), number of sites and subjects, device type and invasiveness, and requested limits. There is no single price; specialist insurers and brokers quote based on your submission pack.
Use our clinical trial insurance cost calculator for an indicative range in 30 seconds, then use the readiness checker above to gather the data insurers need, build your submission pack PDF, and route to three specialist markets to get comparable clinical trial insurance quotes quickly (typically 24–48 hours for initial responses).
About this guide & why you can trust it (E-E-A-T)
This page is designed to match the terms and requirements that sponsors, sites, and ethics committees actually use when requesting clinical trial insurance, clinical trial liability insurance, and clinical trial indemnity.
Experience
Cruxi routes clinical trial insurance requests to specialist insurers and brokers (not generalist brokers). The readiness checker and submission pack reflect the same data points those specialists ask for, so your pack is quote-ready.
Expertise & sources
Content is aligned to insurer and regulatory language from Chubb, Allianz, Howden, Alan Boswell, HRA, NHS, DAIDS RSC, and ClinRegs. Terminology (e.g. clinical trials liability, no-fault compensation, COI wording) mirrors what appears in real policy and ethics requirements.
Trust & transparency
Cruxi is a marketplace and routing service; we do not act as an insurance broker or underwriter. We do not provide legal or insurance advice. Links to official sources (HRA, NHS, Allianz, etc.) are provided so you can verify requirements yourself.
Key sources used on this page
How it works
Check readiness
We highlight likely limits, COI wording, and missing items that usually slow quotes.
Build submission pack
Download a clean PDF with the exact data most specialist markets ask for.
Route to specialists
We handpick 3 specialist markets from our best-fit provider network, so you receive comparable quotes and clear next steps within 24-48 hours.
FAQ
Who needs clinical trial insurance?
Sponsors of clinical trials (including pharma, biotech, and MedTech/IVD companies), CROs, and sometimes sites or investigators need clinical trial insurance or clinical trial liability insurance. UK, EU, and many ethics committees require evidence of insurance or indemnity before study start.
How much does clinical trial insurance cost?
Clinical trial insurance cost depends on study stage (e.g. first-in-human vs post-market), geography, number of sites and subjects, device invasiveness, and limits. Getting a submission pack ready and routing to specialist markets is the fastest way to obtain comparable quotes.
How fast can I get quotes?
We route your submission pack to specialist markets. Initial responses are typically 24 to 48 hours.
Do I need insurance before I start recruitment?
Most sponsors and sites require a bindable quote or proof of insurance before study start and site activation.
What is the minimum data needed to quote?
At minimum: geography, study stage, number of sites and subjects, device type and invasiveness, start date, and requested limits.
Can you handle multi-country trials?
Yes. The readiness checker highlights territory and COI wording requirements for multi-country studies.
Clinical trials liability vs clinical trial indemnity — what is the difference?
In practice, insurers often use these terms interchangeably. "Clinical trials liability" typically refers to coverage for trial-related injury claims, while "indemnity" emphasizes the sponsor or investigator obligation to compensate participants. Your broker can align the exact wording needed by sites and ethics committees.