Clinical Trials Insurance Coverage Checklist
The coverages a clinical trials business may carry — core, prevalent, and situational — why each matters, and the gap most often missed.
Pull out your current policy and check the box next to any coverage you can confirm is already in place — anything unchecked is worth a quick conversation with your advisor. Coverage checklist for drug, biologic, device, and academic sponsors running clinical trials. Priorities reflect typical exposure for this class; confirm against your actual protocols, countries, and contracts.
Tick each coverage you can confirm you carry — anything left unticked is a good question for your next policy review.
| Have it? | Coverage | Why this business needs it | Priority |
|---|---|---|---|
| Clinical Trials Liability | Covers injury to trial participants — schedule every protocol, phase, and country. | Core | |
| Local Country Trial Insurance | Many countries require a locally issued trial policy or certificate before enrollment. | Core | |
| Products Liability | Covers the study product once it is sold or used outside a trial. | Core | |
| Directors & Officers Liability | Covers leadership against investor claims after trial setbacks. | Core | |
| General Liability | Covers offices, labs, and visitors. | Prevalent | |
| Cyber / Privacy Liability | Covers participant health data held by you or your vendors. | Prevalent | |
| Workers' Compensation | Covers employees, including clinical staff and monitors. | Prevalent | |
| Product Recall / Withdrawal | Pays to recall study product if a manufacturing problem is found. | Situational | |
| Transit / Cargo | Covers study drug and samples shipped to sites and labs. | Situational | |
| Errors & Omissions | Covers claims from partners over study design or data handling. | Situational |
The coverage gap most often missed
The gap most often missed by clinical trial sponsors is a mismatch between the policy and the trial paperwork. Informed consent forms and CRO or site contracts often promise more than the policy delivers — CROs commonly ask for $10 million limits, additional insured status, or payment for injuries regardless of fault — and policies may exclude healthy volunteers or countries not scheduled. Read the policy against every protocol, consent form, and contract before first enrollment and at each renewal.
Send us the checklist and we'll review your clinical trials coverage line by line, then market it across multiple carriers that compete for your account.
Related: Clinical Trials Insurance · Clinical Trials Supplemental (apply) · All coverage checklists
Frequently asked questions
What insurance does a clinical trials business need?
The core coverages for a clinical trials business are Clinical Trials Liability, Local Country Trial Insurance, Products Liability, Directors & Officers Liability. This checklist also lists the prevalent and situational coverages worth considering, with a plain-English note on why each matters.
Is this checklist insurance advice?
No. It is a free educational tool to help you have a more informed conversation with a licensed professional. It affords no coverage and is not insurance, legal, or financial advice — only your actual policy language governs what is and isn't covered.
Can Cory Washington & Co. review my clinical trials coverage?
Yes. Share your checklist and we'll review your program line by line, market your account across multiple carriers, and explain the trade-offs in plain English. Cory Washington & Co. LLC is licensed in all 50 states.
This checklist is a free educational tool from Cory Washington & Co. to help you review your own coverage and have a more informed conversation with a licensed insurance professional. It is general information only — not insurance, legal, or financial advice, and not a recommendation to buy, change, or cancel any policy. Coverage terms, availability, limits, and requirements vary by policy, carrier, and state, and only the language in your actual policy governs what is and isn’t covered. Checking or leaving blank any item above does not indicate that you are adequately insured or under-insured. Using this checklist does not create a client, agency, or fiduciary relationship. Always consult a licensed professional about your specific situation.